The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for S/5 Compact Anesthesia Monitor With S-00a05, S-00a06. L-00a07, L00a08.
| Device ID | K002478 |
| 510k Number | K002478 |
| Device Name: | S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-11 |
| Decision Date | 2000-10-05 |