K022193 is an FDA 510(k) clearance for the DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Ge Medical Systems Information Technologies (Tampa, US). The FDA issued a Cleared decision on August 1, 2002, 27 days after receiving the submission on July 5, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K022193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2002 |
| Decision Date | August 01, 2002 |
| Days to Decision | 27 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 |