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 Camera, Scintillation (Gamma)
510(k) Number K923180
Device Name SPECTURN, MODEL TTK-128
Applicant
Harpell Assoc., Inc.
1272 Speers Rd., Unit 2
Oakville, Ontario,  CA L6L 2X4
Applicant Contact TIM HARPELL
Correspondent
Harpell Assoc., Inc.
1272 Speers Rd., Unit 2
Oakville, Ontario,  CA L6L 2X4
Correspondent Contact TIM HARPELL
Regulation Number892.1100
Classification Product Code
IYX  
Date Received06/30/1992
Decision Date 07/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-