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 System, Telethermographic (Adjunctive Use)
510(k) Number K212965
Device Name Smile-100 System
Applicant
Niramai Health Analytix Private Limited
Innova Pearl, Ground Floor, #17, 5th Block, Koramangala
Industrial, Layout, Koramangala
Bangalore,  IN 560095
Applicant Contact Geetha Manjunath
Correspondent
Smith Associates
1468 Harvell Ave.
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received09/16/2021
Decision Date 03/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-