The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Etco2 Cartridge.
Device ID | K905775 |
510k Number | K905775 |
Device Name: | SIEMENS ETCO2 CARTRIDGE |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
Contact | Robert R Murfitt |
Correspondent | Robert R Murfitt SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-27 |
Decision Date | 1991-03-11 |