K922479 is an FDA 510(k) clearance for the DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED. 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 October 30, 1992, 157 days after receiving the submission on May 26, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5975.
| 510(k) Number | K922479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1992 |
| Decision Date | October 30, 1992 |
| Days to Decision | 157 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 |