K821144 is an FDA 510(k) clearance for the OHIO ABSORBER. This device is classified as a Absorber, Carbon-dioxide (Class I - General Controls, product code BSF).
Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 37 days after receiving the submission on April 21, 1982.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5310.
| 510(k) Number | K821144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSF — Absorber, Carbon-dioxide |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5310 |