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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device device system, imaging, tympanic membrane and middle ear
Regulation Description Ultrasonic pulsed echo imaging system.
Definition Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
Product CodeQJG
Regulation Number 892.1560
Device Class 2


Premarket Reviews
ManufacturerDecision
PHOTONICARE, INC
  SUBSTANTIALLY EQUIVALENT 1

-
-