The following data is part of a premarket notification filed by Vital Signs Colorado, Inc. with the FDA for Imask, Models 100, 200 And 300.
| Device ID | K051559 |
| 510k Number | K051559 |
| Device Name: | IMASK, MODELS 100, 200 AND 300 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | VITAL SIGNS COLORADO, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | Tom Dielmann |
| Correspondent | Tom Dielmann VITAL SIGNS COLORADO, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-13 |
| Decision Date | 2005-07-08 |