• 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, Pressure Measurement, Intermittent
510(k) Number K913510
Device Name MECHANICAL SHAPE SENSOR
Applicant
Pin Dot Products, Inc.
6001 Gross Pt. Rd.
Niles,  IL  60648
Correspondent
Pin Dot Products, Inc.
6001 Gross Pt. Rd.
Niles,  IL  60648
Regulation Number890.1600
Classification Product Code
JFC  
Date Received08/07/1991
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-