K862784 is an FDA 510(k) clearance for the MP-XMO DISPOSABLE FACE MASK. This device is classified as a Mask, Gas, Anesthetic (Class I - General Controls, product code BSJ).
Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on August 1, 1986, 9 days after receiving the submission on July 23, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5550.
| 510(k) Number | K862784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1986 |
| Decision Date | August 01, 1986 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSJ — Mask, Gas, Anesthetic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5550 |