The following data is part of a premarket notification filed by Pan-america Hyperbarics, Inc. with the FDA for Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1.
| Device ID | K122560 |
| 510k Number | K122560 |
| Device Name: | VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PAN-AMERICA HYPERBARICS, INC. 1510 PARK PLACE DRIVE Atchison, KS 66002 |
| Contact | William M Gates, Rrt |
| Correspondent | William M Gates, Rrt PAN-AMERICA HYPERBARICS, INC. 1510 PARK PLACE DRIVE Atchison, KS 66002 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-22 |
| Decision Date | 2013-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872000006 | K122560 | 000 |