The following data is part of a premarket notification filed by Respcare Inc. with the FDA for Respcare Face Mask.
| Device ID | K052227 |
| 510k Number | K052227 |
| Device Name: | RESPCARE FACE 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-16 |
| Decision Date | 2005-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411942478 | K052227 | 000 |
| 10607411942461 | K052227 | 000 |
| 10607411942454 | K052227 | 000 |
| 10607411942447 | K052227 | 000 |
| 10607411942430 | K052227 | 000 |
| 10607411942423 | K052227 | 000 |
| 10607411942416 | K052227 | 000 |
| 10607411942409 | K052227 | 000 |
| 10607411942393 | K052227 | 000 |