K893532 is an FDA 510(k) clearance for the RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963. This device is classified as a Apparatus, Gas-scavenging (Class II - Special Controls, product code CBN).
Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on August 21, 1989, 105 days after receiving the submission on May 8, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5430.
| 510(k) Number | K893532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1989 |
| Decision Date | August 21, 1989 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBN — Apparatus, Gas-scavenging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5430 |