The following data is part of a premarket notification filed by Respcare Inc. with the FDA for Respcare Hybrid Av Mask.
| Device ID | K062224 |
| 510k Number | K062224 |
| Device Name: | RESPCARE HYBRID AV MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPCARE INC. 6601 LYONS ROAD, SUITES B1-B4 Coconut Creek, FL 33073 |
| Contact | Frank Pelc |
| Correspondent | Frank Pelc 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2006-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411943765 | K062224 | 000 |
| 10607411943758 | K062224 | 000 |
| 10607411943741 | K062224 | 000 |