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 Transducer, Tremor
510(k) Number K010270
Device Name TREMOROMETER
Applicant
Flexable Systems, Inc.
16410 E. Tomstone Ave.
Fountain Hills,  AZ  85268 -6545
Applicant Contact ROBERT M TRIPP
Correspondent
Flexable Systems, Inc.
16410 E. Tomstone Ave.
Fountain Hills,  AZ  85268 -6545
Correspondent Contact ROBERT M TRIPP
Regulation Number882.1950
Classification Product Code
GYD  
Date Received01/29/2001
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-