K880637 is an FDA 510(k) clearance for the BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES. This device is classified as a Set, Tubing And Support, Ventilator (w Harness) (Class I - General Controls, product code BZO).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on April 11, 1988, 55 days after receiving the submission on February 16, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5975.
| 510(k) Number | K880637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1988 |
| Decision Date | April 11, 1988 |
| Days to Decision | 55 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 |