Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K022864
Device Name SK MED M201 MIXER
Applicant
SK MED
16000 SHERMAN WAY #224
VAN NUYS,  CA  91406
Applicant Contact DIPAK GHOSH
Correspondent
SK MED
16000 SHERMAN WAY #224
VAN NUYS,  CA  91406
Correspondent Contact DIPAK GHOSH
Regulation Number868.5330
Classification Product Code
BZR  
Subsequent Product Code
CCL  
Date Received08/28/2002
Decision Date 04/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-