510(k) K193534
K193534 is an FDA 510(k) premarket notification submitted by Auris Health, Inc. for the device "Monarch Platform". The FDA issued a decision of Substantially Equivalent on April 15, 2020. The device falls under product code EOQ (Bronchoscope (Flexible Or Rigid)), a Class II device regulated under 21 CFR 874.4680. Auris Health, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2020
- Date Received
- December 20, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bronchoscope (Flexible Or Rigid)
- Device Class
- Class II
- Regulation Number
- 874.4680
- Review Panel
- EN
- Submission Type
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).