The following data is part of a premarket notification filed by Pan-america Hyperbarics, Inc. with the FDA for Pan-america Hyperbarics Hyperbaric Chamber System, Model Pah-s1.
| Device ID | K021693 |
| 510k Number | K021693 |
| Device Name: | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1 |
| Classification | Chamber, Hyperbaric |
| Applicant | PAN-AMERICA HYPERBARICS, INC. 18111 COPPER RIDGE DR. San Antonio, TX 78259 -3612 |
| Contact | W.t. Workman |
| Correspondent | W.t. Workman PAN-AMERICA HYPERBARICS, INC. 18111 COPPER RIDGE DR. San Antonio, TX 78259 -3612 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-22 |
| Decision Date | 2002-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872000013 | K021693 | 000 |