Submission Details
| 510(k) Number | K880683 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 1988 |
| Decision Date | March 09, 1988 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K880683 is an FDA 510(k) clearance for the KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT, a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I — General Controls, product code CAI), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 9, 1988, 19 days after receiving the submission on February 19, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5240.
| 510(k) Number | K880683 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 1988 |
| Decision Date | March 09, 1988 |
| Days to Decision | 19 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 |