K920699 is an FDA 510(k) clearance for the REMSTAR WTIH RAMP AND REMOTE MODIFICATION. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on December 7, 1992, 313 days after receiving the submission on January 29, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K920699 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1992 |
| Decision Date | December 07, 1992 |
| Days to Decision | 313 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 |