The following data is part of a premarket notification filed by Westmed, Inc. with the FDA for Co2 Easy.
Device ID | K070128 |
510k Number | K070128 |
Device Name: | CO2 EASY |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | Westmed, Inc. 5580 S. NOGALES HIGHWAY Tucson, AZ 85706 |
Contact | Dale Bickley |
Correspondent | Neil E Devine, Jr. INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-01-16 |
Decision Date | 2007-02-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CO2 EASY 77037760 3395431 Live/Registered |
WestMed, Inc. 2006-11-06 |