Submission Details
| 510(k) Number | K834570 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 1983 |
| Decision Date | March 05, 1984 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K834570 is an FDA 510(k) clearance for the VOLUME VENTILATOR CIRCUIT W/WATER TRAP, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984, 67 days after receiving the submission on December 29, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.
| 510(k) Number | K834570 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 1983 |
| Decision Date | March 05, 1984 |
| Days to Decision | 67 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 |