Submission Details
| 510(k) Number | K962713 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 1996 |
| Decision Date | October 23, 1996 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
K962713 is an FDA 510(k) clearance for the DPAP STEALTH SLEEPNET MODEL NUMBER 84000, 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 October 23, 1996, 103 days after receiving the submission on July 12, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K962713 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 1996 |
| Decision Date | October 23, 1996 |
| Days to Decision | 103 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 |