K912880 is an FDA 510(k) clearance for the VITALMAX 510/520. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on November 14, 1991, 136 days after receiving the submission on July 1, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K912880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1991 |
| Decision Date | November 14, 1991 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |