The following data is part of a premarket notification filed by Sands Hyperbarics with the FDA for Sands Series Iii Hyperbaric Chamber.
| Device ID | K972908 |
| 510k Number | K972908 |
| Device Name: | SANDS SERIES III HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | SANDS HYPERBARICS 709 EAST WASHINGTON BLVD. Los Angeles, CA 90021 |
| Contact | Lachlan Sands |
| Correspondent | Lachlan Sands SANDS HYPERBARICS 709 EAST WASHINGTON BLVD. Los Angeles, CA 90021 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-06 |
| Decision Date | 1998-07-22 |
| Summary: | summary |