The following data is part of a premarket notification filed by Innomed Technologies with the FDA for It Nasal Mask.
| Device ID | K050171 |
| 510k Number | K050171 |
| Device Name: | IT NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | INNOMED TECHNOLOGIES 6601 LYONS ROAD SUITES B1-B-4 Coconut Creek, FL 33073 |
| Contact | Frank Pelc |
| Correspondent | Frank Pelc INNOMED TECHNOLOGIES 6601 LYONS ROAD SUITES B1-B-4 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 | 2005-01-26 |
| Decision Date | 2005-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411945547 | K050171 | 000 |
| 10607411942133 | K050171 | 000 |
| 10607411942140 | K050171 | 000 |
| 10607411942157 | K050171 | 000 |
| 10607411942164 | K050171 | 000 |
| 10607411942171 | K050171 | 000 |
| 10607411942188 | K050171 | 000 |
| 10607411942195 | K050171 | 000 |
| 10607411945479 | K050171 | 000 |
| 10607411945486 | K050171 | 000 |
| 10607411945493 | K050171 | 000 |
| 10607411945509 | K050171 | 000 |
| 10607411945516 | K050171 | 000 |
| 10607411945523 | K050171 | 000 |
| 10607411945530 | K050171 | 000 |
| 10607411942126 | K050171 | 000 |