K830470 is an FDA 510(k) clearance for the ANESTHESIA BREATHING CIRCUITS. This device is classified as a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I - General Controls, product code CAI).
Submitted by Mon-A-Therm, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983, 37 days after receiving the submission on February 15, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5240.
| 510(k) Number | K830470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 1983 |
| Decision Date | March 24, 1983 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAI — Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5240 |