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 System, Monitoring, Perinatal
510(k) Number K942887
Device Name MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
Applicant
Hewlett-Packard Co.
175 Waltham St.
P.O.Box 9030
Waltham,  MA  02254
Applicant Contact MONICA FERRANTE
Correspondent
Hewlett-Packard Co.
175 Waltham St.
P.O.Box 9030
Waltham,  MA  02254
Correspondent Contact MONICA FERRANTE
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/20/1994
Decision Date 08/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-