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SUMMIT TO SEA, LLC · Model The Grand Dive Hyperbaric Chamber · UDI-DI 00866115000324
1
510(k) clearances
153
Adverse events (12 deaths)
3
Recalls
18
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-08-08 | Baro-Therapies, Inc | The firm is distributing the Rejuvenator device without an approved 510(k). |
| 2008-08-28 | Sechrist Industries Inc | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform |
| 2008-08-28 | Sechrist Industries Inc | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.