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 Lamp, Infrared, Therapeutic Heating
510(k) Number K101693
Device Name GAUNYING INFRARED LAMP MODEL IL50
Applicant
Foshan Gaunying Electronics Co., Ltd.
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Applicant Contact GUENTER GINSBERG
Correspondent
Foshan Gaunying Electronics Co., Ltd.
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/16/2010
Decision Date 01/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-