K790638 is an FDA 510(k) clearance for the ACCUTRON POLLUTION REDUCER. This device is classified as a Mask, Gas, Anesthetic (Class I - General Controls, product code BSJ).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1979, 56 days after receiving the submission on March 30, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5550.
| 510(k) Number | K790638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1979 |
| Decision Date | May 25, 1979 |
| Days to Decision | 56 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 |