The following data is part of a premarket notification filed by Dispo-med (malaysia) Sdn Bhd with the FDA for Co2-mas, Oxygen Delivery/ Co2 Sampling Cannula Style, Co2 Sampling Only Style.
Device ID | K143127 |
510k Number | K143127 |
Device Name: | CO2-Mas, Oxygen Delivery/ CO2 Sampling Cannula Style, CO2 Sampling Only Style |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | DISPO-MED (MALAYSIA) SDN BHD 21, JALAN TEKNOLOGI 3/5A, PUSAT TEKNOLOGI SINAR DAMANSARA, KOTA DAMANSARA Petaling Jaya , Selangor Darul Ehsan, MY 47810 |
Contact | Nc Leow |
Correspondent | Paul Dryden DISPO-MED (MALAYSIA) SDN BHD 21, JALAN TEKNOLOGI 3/5A, PUSAT TEKNOLOGI SINAR DAMANSARA, KOTA DAMANSARA Petaling Jaya , Selangor Darul Ehsan, MY 47810 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-31 |
Decision Date | 2015-02-13 |
Summary: | summary |