K901060 is an FDA 510(k) clearance for the EDENTEC MODEL 2000W SYSTEM 700 MONITOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on May 15, 1990, 70 days after receiving the submission on March 6, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K901060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1990 |
| Decision Date | May 15, 1990 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |