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-m3+1.
Device ID | K021690 |
510k Number | K021690 |
Device Name: | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1 |
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 |