The following data is part of a premarket notification filed by Datex Medical Instrumentation, Inc. with the FDA for As/3 Compact Airway Module M-caiov.
| Device ID | K960490 |
| 510k Number | K960490 |
| Device Name: | AS/3 COMPACT AIRWAY MODULE M-CAIOV |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| 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 | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-02 |
| Decision Date | 1996-05-03 |
| Summary: | summary |