The following data is part of a premarket notification filed by Clarus Medical, Llc. with the FDA for Clarus Video Airway Endoscope, Models 30000-v And 30003-v.
| Device ID | K082038 |
| 510k Number | K082038 |
| Device Name: | CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH SUITE 300 Minneapolis, MN 55427 |
| Contact | Thomas Barthel |
| Correspondent | Thomas Barthel CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH SUITE 300 Minneapolis, MN 55427 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-17 |
| Decision Date | 2009-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B06730000V0 | K082038 | 000 |