K911328 is an FDA 510(k) clearance for the UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION. This device is classified as a Set, Tubing And Support, Ventilator (w Harness) (Class I - General Controls, product code BZO).
Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on August 15, 1991, 142 days after receiving the submission on March 26, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5975.
| 510(k) Number | K911328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1991 |
| Decision Date | August 15, 1991 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZO — Set, Tubing And Support, Ventilator (w Harness) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5975 |