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 Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K895185
Device Name FIRST MEDIC MODEL 610P
Applicant
First Medical Devices Corp.
2445 140th Ave. NE Suite 150
(Per Do, Firm Oob)
Bellevue,  WA  98005
Applicant Contact BRUCE G HAGGAR
Correspondent
First Medical Devices Corp.
2445 140th Ave. NE Suite 150
(Per Do, Firm Oob)
Bellevue,  WA  98005
Correspondent Contact BRUCE G HAGGAR
Regulation Number870.5300
Classification Product Code
LDD  
Date Received08/11/1989
Decision Date 10/27/1989
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
-
-