The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for As/3 Anesthesia Montior With S-ane99(a)/l-ark99(a).
| Device ID | K000815 |
| 510k Number | K000815 |
| Device Name: | AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DATEX-OHMEDA THREE HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA THREE 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 | 2000-03-13 |
| Decision Date | 2000-06-08 |