The following data is part of a premarket notification filed by Perry Baromedical Services with the FDA for Sigma Ii - Dual Place Hyperbaric Chamber.
| Device ID | K862198 |
| 510k Number | K862198 |
| Device Name: | SIGMA II - DUAL PLACE HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | PERRY BAROMEDICAL SERVICES C/O MEDICAL DEVICE INSPECTION CO., 55 NORTHERN BLVD. STE 205 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz PERRY BAROMEDICAL SERVICES C/O MEDICAL DEVICE INSPECTION CO., 55 NORTHERN BLVD. STE 205 Great Neck, NY 11021 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-11-12 |