K912065 is an FDA 510(k) clearance for the DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED. This device is classified as a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I - General Controls, product code CAI).
Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on October 23, 1991, 180 days after receiving the submission on April 26, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5240.
| 510(k) Number | K912065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1991 |
| Decision Date | October 23, 1991 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAI — Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5240 |