The following data is part of a premarket notification filed by Performance Hyperbarics with the FDA for Flexi-lite, Model Fl-v1.2.
| Device ID | K051759 |
| 510k Number | K051759 |
| Device Name: | FLEXI-LITE, MODEL FL-V1.2 |
| Classification | Chamber, Hyperbaric |
| Applicant | PERFORMANCE HYPERBARICS 2599 A OLINDA ROAD Makawao, HI 96768 |
| Contact | Spencer Feldman |
| Correspondent | Spencer Feldman PERFORMANCE HYPERBARICS 2599 A OLINDA ROAD Makawao, HI 96768 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-29 |
| Decision Date | 2005-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865439000270 | K051759 | 000 |
| 00852834007027 | K051759 | 000 |
| 00852834007034 | K051759 | 000 |
| 00852834007041 | K051759 | 000 |
| 00852834007058 | K051759 | 000 |
| 00865439000201 | K051759 | 000 |
| 00865439000218 | K051759 | 000 |
| 00865439000225 | K051759 | 000 |
| 00865439000232 | K051759 | 000 |
| 00865439000249 | K051759 | 000 |
| 00865439000256 | K051759 | 000 |
| 00865439000263 | K051759 | 000 |
| 00852834007010 | K051759 | 000 |