The following data is part of a premarket notification filed by Perry Baromedical Corp. with the FDA for Sigma Series Hyperbaric Chamber.
| Device ID | K072427 |
| 510k Number | K072427 |
| Device Name: | SIGMA SERIES HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | PERRY BAROMEDICAL CORP. 3660 INTERSTATE PKWY. Riviera Beach, FL 33404 |
| Contact | John Crocker |
| Correspondent | John Crocker PERRY BAROMEDICAL CORP. 3660 INTERSTATE PKWY. Riviera Beach, FL 33404 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-29 |
| Decision Date | 2008-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852678007115 | K072427 | 000 |
| 00852678007061 | K072427 | 000 |
| 00852678007054 | K072427 | 000 |
| 00852678007047 | K072427 | 000 |