The following data is part of a premarket notification filed by Cnsystems Medizintechnik Gmbh with the FDA for Task Force Monitor 3040.
Device ID | K014063 |
510k Number | K014063 |
Device Name: | TASK FORCE MONITOR 3040 |
Classification | Plethysmograph, Impedance |
Applicant | CNSYSTEMS MEDIZINTECHNIK GMBH BAUMKIRCHERSTRASSE 1 A-8020 GRAZ Europe, AT |
Contact | Christian Wagner |
Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | DSB |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2001-12-11 |
Decision Date | 2002-02-07 |
Summary: | summary |