K953697 is an FDA 510(k) clearance for the THE IMS DPAP MASK, IMS MODEL NUMBER 82000. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on June 13, 1996, 310 days after receiving the submission on August 8, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K953697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1995 |
| Decision Date | June 13, 1996 |
| Days to Decision | 310 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |