K102835 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on December 27, 2010, 89 days after receiving the submission on September 29, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K102835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2010 |
| Decision Date | December 27, 2010 |
| Days to Decision | 89 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 |