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 |