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, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K881643
Device Name BATTERY PACKS FOR CARDIOVASCULAR UNITS
Applicant
Dowit Service Co., Inc.
P.O. Box 433
Towaco,  NJ  07082
Applicant Contact JOAN POTOSNAK
Correspondent
Dowit Service Co., Inc.
P.O. Box 433
Towaco,  NJ  07082
Correspondent Contact JOAN POTOSNAK
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Code
LDD  
Date Received04/04/1988
Decision Date 05/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-