K021955 is an FDA 510(k) clearance for the TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES. 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 October 8, 2002, 116 days after receiving the submission on June 14, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K021955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2002 |
| Decision Date | October 08, 2002 |
| Days to Decision | 116 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 |