The following data is part of a premarket notification filed by Datex Medical Instrumentation, Inc. with the FDA for As/3 Cardiac Output & Svo2 Module.
| Device ID | K961063 |
| 510k Number | K961063 |
| Device Name: | AS/3 CARDIAC OUTPUT & SVO2 MODULE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | DATEX MEDICAL INSTRUMENTATION, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Vincent Rauscher |
| Correspondent | Vincent Rauscher DATEX MEDICAL INSTRUMENTATION, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-18 |
| Decision Date | 1996-05-31 |
| Summary: | summary |