K881141 is an FDA 510(k) clearance for the PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT. This device is classified as a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I - General Controls, product code CAI).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on April 25, 1988, 39 days after receiving the submission on March 17, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5240.
| 510(k) Number | K881141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1988 |
| Decision Date | April 25, 1988 |
| Days to Decision | 39 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 |