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 |