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 exerciser, measuring
510(k) Number K933611
Device Name THE BTE WS30
Applicant
BALTIMORE THERAPEUTIC EQUIPMENT CO.
7455 L NEW RIDGE RD.
HANOVER,  MD  21076
Applicant Contact JOHN VERMETTE
Correspondent
BALTIMORE THERAPEUTIC EQUIPMENT CO.
7455 L NEW RIDGE RD.
HANOVER,  MD  21076
Correspondent Contact JOHN VERMETTE
Regulation Number890.5360
Classification Product Code
ISD  
Date Received07/19/1993
Decision Date 06/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-