K052755 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on October 13, 2005, 13 days after receiving the submission on September 30, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K052755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2005 |
| Decision Date | October 13, 2005 |
| Days to Decision | 13 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 |