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510(k) K203614

Monarch Bronchoscope by Auris Health, Inc., A Johnson and Johnson Family Company — Product Code QNW

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.

Other clearances by Auris Health, Inc., A Johnson and Johnson Family Company

  • K231473 — Monarch Bronchoscope (November 28, 2023)

Other clearances for product code QNW

  • K231473 — Monarch Bronchoscope (November 28, 2023)