K993608 is an FDA 510(k) clearance for the DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR). This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Datex-Ohmeda, Inc. (Tewksburt, US). The FDA issued a Cleared decision on April 13, 2000, 171 days after receiving the submission on October 25, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K993608 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1999 |
| Decision Date | April 13, 2000 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |