The following data is part of a premarket notification filed by Hypertec, Inc. with the FDA for Model 5000 Multiplace Hyperbaric Therapy.
| Device ID | K002794 |
| 510k Number | K002794 |
| Device Name: | MODEL 5000 MULTIPLACE HYPERBARIC THERAPY |
| Classification | Chamber, Hyperbaric |
| Applicant | HYPERTEC, INC. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm HYPERTEC, INC. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-07 |
| Decision Date | 2000-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08906124940005 | K002794 | 000 |
| 08906124943068 | K002794 | 000 |
| 08906124943051 | K002794 | 000 |