The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for As/3(tm) Anesthesia Monitor Syst Interface Board.
Device ID | K935477 |
510k Number | K935477 |
Device Name: | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
Contact | Hannu Ahjopalo |
Correspondent | Hannu Ahjopalo DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-15 |
Decision Date | 1994-08-01 |