K062576 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on September 29, 2006, 29 days after receiving the submission on August 31, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K062576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2006 |
| Decision Date | September 29, 2006 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |