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 monitor, uterine contraction, external (for use in clinic)
510(k) Number K860933
Device Name AIR-CUSHION TOCOTONOMETER
Applicant
INTERNATIONAL BIOMEDICS, INC.
1631 220TH AVE. S.E.
(PER DO, FIRM OOB)
BOTHELL,  WA  98021
Applicant Contact HOWARD M HOCHBERG
Correspondent
INTERNATIONAL BIOMEDICS, INC.
1631 220TH AVE. S.E.
(PER DO, FIRM OOB)
BOTHELL,  WA  98021
Correspondent Contact HOWARD M HOCHBERG
Regulation Number884.2720
Classification Product Code
HFM  
Date Received03/12/1986
Decision Date 07/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-