SK MED M201 PLUS MIXER

Mixer, Breathing Gases, Anesthesia Inhalation

SK MED

The following data is part of a premarket notification filed by Sk Med with the FDA for Sk Med M201 Plus Mixer.

Pre-market Notification Details

Device IDK031707
510k NumberK031707
Device Name:SK MED M201 PLUS MIXER
ClassificationMixer, Breathing Gases, Anesthesia Inhalation
Applicant SK MED 16000 SHERMAN WAY #224 Van Nuys,  CA  91406
ContactDipak Ghosh
CorrespondentDipak Ghosh
SK MED 16000 SHERMAN WAY #224 Van Nuys,  CA  91406
Product CodeBZR  
CFR Regulation Number868.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-02
Decision Date2003-08-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.