K840452 is an FDA 510(k) clearance for the PREMIUM DABM DISPOS. ANES. BREATH MASK. This device is classified as a Mask, Gas, Anesthetic (Class I - General Controls, product code BSJ).
Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984, 16 days after receiving the submission on February 1, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5550.
| 510(k) Number | K840452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1984 |
| Decision Date | February 17, 1984 |
| Days to Decision | 16 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 |