K993512 is an FDA 510(k) clearance for the DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Datex-Ohmeda, Inc. (Louisville, US). The FDA issued a Cleared decision on March 31, 2000, 165 days after receiving the submission on October 18, 1999.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K993512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1999 |
| Decision Date | March 31, 2000 |
| Days to Decision | 165 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |