The following data is part of a premarket notification filed by Datex Medical Instrumentation, Inc. with the FDA for As/3 Network Link.
Device ID | K953006 |
510k Number | K953006 |
Device Name: | AS/3 NETWORK LINK |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
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 | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-28 |
Decision Date | 1995-09-27 |