K932712 is an FDA 510(k) clearance for the PRECISION MED PRODUCTS LTD VOLUME VENTILATORS. This device is classified as a Set, Tubing And Support, Ventilator (w Harness) (Class I - General Controls, product code BZO).
Submitted by Precision Med Products, Ltd. (Marrtinsville, US). The FDA issued a Cleared decision on July 22, 1993, 48 days after receiving the submission on June 4, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5975.
| 510(k) Number | K932712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1993 |
| Decision Date | July 22, 1993 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZO — Set, Tubing And Support, Ventilator (w Harness) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5975 |