510(k) K203614
K203614 is an FDA 510(k) premarket notification submitted by Auris Health, Inc., A Johnson and Johnson Family Company for the device "Monarch Bronchoscope". The FDA issued a decision of Substantially Equivalent on March 11, 2021. The device falls under product code QNW (Reprocessed Bronchoscope), a Class II device regulated under 21 CFR 874.4680. Auris Health, Inc., A Johnson and Johnson Family Company has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2021
- Date Received
- December 10, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reprocessed Bronchoscope
- Device Class
- Class II
- Regulation Number
- 874.4680
- Review Panel
- EN
- Submission Type
Same as EOQ except reprocessed. Please see EOQ at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EOQ Reprocessing validation data for this device type must be included in a 510(k) submission.