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 Gas-Machine, Anesthesia
510(k) Number K935546
Device Name MAC/IV SEDATION KIT
Applicant
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Applicant Contact JING ZHANG
Correspondent
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Correspondent Contact JING ZHANG
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received11/17/1993
Decision Date 06/13/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-