The following data is part of a premarket notification filed by Hyperbaric For Life Llc with the FDA for Millenium, Models 2000, 2001 And 2002.
| Device ID | K041007 |
| 510k Number | K041007 |
| Device Name: | MILLENIUM, MODELS 2000, 2001 AND 2002 |
| Classification | Chamber, Hyperbaric |
| Applicant | HYPERBARIC FOR LIFE LLC 3206 WEST STATE AVE. Phoenix, AZ 85051 |
| Contact | Rick Ryder |
| Correspondent | Rick Ryder HYPERBARIC FOR LIFE LLC 3206 WEST STATE AVE. Phoenix, AZ 85051 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2004-11-15 |