The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Imask Tm.
| Device ID | K041309 |
| 510k Number | K041309 |
| Device Name: | IMASK TM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE Englewood, CO |
| Contact | Thomas Dielmann |
| Correspondent | Thomas Dielmann VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE Englewood, CO |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-17 |
| Decision Date | 2004-06-30 |
| Summary: | summary |