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Product photo not verified

FDA record available. Official manufacturer image review is pending.

Hospital supply

Source-backed beta record

Source-backed listing

MONARCH™ Platform (MON-000008)

No public price verified

This beta record is generated from the linked openFDA 510(k) dataset. It establishes a public regulatory record, not current sale status, suitability, or manufacturer identity beyond the named applicant.

Use this record to find the FDA decision and identifier. Verify current labeling and manufacturer information before relying on it.

Information boundary

Information only. Aidlyst does not sell this device or verify its current availability, labeling, compatibility, or suitability.

FDA product code

EOQ

Regulatory class

Class 2

510(k)

K260382

Regulation number

874.4680

Availability

FDA 510(k) decision record located; commercial availability and inventory not verified

Manufacturer

Auris Health, Inc.

Aidlyst relationship

Independent public-record index; no commercial relationship asserted

Last reviewed

August 10, 2026

FDA source510(k) decisionPrice not verified
Open FDA record Share feedback

Transparent price evidence

Observed prices and estimate

Observations are linked to their public pages. Aidlyst does not sell this product, verify inventory, or represent these values as quotes.

Worldwide estimate unavailable

No public manufacturer or distributor price was verified for this generated FDA record.

Evidence trail

Regulatory
FDA 510(k) record K260382Regulatory
openFDA 510(k) dataset

Care or facility context

  • - Ear, Nose, Throat regulatory category; specific intended use requires source review.

Included sample items

  • - Package contents not verified from the FDA index record

Compatibility notes

  • - Compatibility information not verified

What to confirm

  • - Does the current labeling cover the intended use?
  • - Is this exact model currently marketed by the named applicant or a successor?
  • - What training, accessories, or clinical oversight are required?

Information notice

  • - Generated from a public FDA 510(k) index record.
  • - FDA clearance is not an endorsement, registration guarantee, or individualized recommendation.
  • - No product photograph, manufacturer product page, or public price has been verified for this record.