The following data is part of a premarket notification filed by Ameriflo Corp. with the FDA for Flo-rite, Model 478-1; Flo-rite Ii, Model 478-1; Simpulse Ii, Model 478-2s; Numatix, Model Ncd401; Simpulse, Model 478-1.
| Device ID | K060382 |
| 510k Number | K060382 |
| Device Name: | FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1 |
| Classification | Conserver, Oxygen |
| Applicant | AMERIFLO CORP. 478 GRADLE DR. Carmel, IN 46032 |
| Contact | Matthew Thie |
| Correspondent | Matthew Thie AMERIFLO CORP. 478 GRADLE DR. Carmel, IN 46032 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-04-19 |
| Summary: | summary |