Submission Details
| 510(k) Number | K022485 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 2002 |
| Decision Date | October 03, 2002 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K022485 - DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
(FDA 510(k) Clearance)
Oct 2002
Decision
66d
Days
Class 2
Risk
K022485 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on October 3, 2002, 66 days after receiving the submission on July 29, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.
Device Classification
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1025 |
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