The following data is part of a premarket notification filed by Makai Marine Industries, Inc. with the FDA for Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System.
| Device ID | K030418 |
| 510k Number | K030418 |
| Device Name: | MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM |
| Classification | Chamber, Hyperbaric |
| Applicant | MAKAI MARINE INDUSTRIES, INC. P.O. BOX 272039 Boca Raton, FL 33427 |
| Contact | Marc R Kaiser |
| Correspondent | Marc R Kaiser MAKAI MARINE INDUSTRIES, INC. P.O. BOX 272039 Boca Raton, FL 33427 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-02-10 |
| Decision Date | 2004-01-29 |
| Summary: | summary |