The following data is part of a premarket notification filed by Innomed Technologies Inc./respcare Inc. with the FDA for Nasal Aire Ii Pediatric, Model 5 Sizes, Model Tbd.
| Device ID | K090804 |
| 510k Number | K090804 |
| Device Name: | NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | INNOMED TECHNOLOGIES INC./RESPCARE INC. 6601 LYONS ROAD SUITES B1-B4 Coconut Creek, FL 33073 |
| Contact | Linda Magill |
| Correspondent | Linda Magill INNOMED TECHNOLOGIES INC./RESPCARE INC. 6601 LYONS ROAD SUITES B1-B4 Coconut Creek, FL 33073 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-11-05 |
| Summary: | summary |