The following data is part of a premarket notification filed by Sk Med with the FDA for Sk Med M201 Plus Mixer.
Device ID | K031707 |
510k Number | K031707 |
Device Name: | SK MED M201 PLUS MIXER |
Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
Applicant | SK MED 16000 SHERMAN WAY #224 Van Nuys, CA 91406 |
Contact | Dipak Ghosh |
Correspondent | Dipak Ghosh SK MED 16000 SHERMAN WAY #224 Van Nuys, CA 91406 |
Product Code | BZR |
CFR Regulation Number | 868.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-02 |
Decision Date | 2003-08-01 |