• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back To Search Results
Device Classification Name oximeter
510(k) Number K910629
Device Name AP-860PA NIBP MODULE
Original Applicant
17112 armstrong ave.
irvine,  CA  92714
Original Contact mike dashefsky
Regulation Number870.2700
Classification Product Code
Date Received02/13/1991
Decision Date 05/14/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No