The following data is part of a premarket notification filed by Steve Islava with the FDA for Care2 Medical Nebulizer, Model 101/102, 201/202.
| Device ID | K091794 |
| 510k Number | K091794 |
| Device Name: | CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | STEVE ISLAVA 1599 SUPERIOR AVE, STE B5 Costa Mesa, CA 92627 |
| Contact | Jim Barley |
| Correspondent | Jim Barley STEVE ISLAVA 1599 SUPERIOR AVE, STE B5 Costa Mesa, CA 92627 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2010-01-28 |
| Summary: | summary |