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 Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K921444
Device Name DIGI SPORTLENS SYSTEM
Applicant
Fitness Quest, Inc.
1375 Raff Rd. SW
Canton,  OH  44750
Applicant Contact DREW H SEVERS
Correspondent
Fitness Quest, Inc.
1375 Raff Rd. SW
Canton,  OH  44750
Correspondent Contact DREW H SEVERS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/25/1992
Decision Date 07/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-