• 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 monitor, breathing frequency
Regulation Description Breathing frequency monitor.
Product CodeBZQ
Regulation Number 868.2375
Device Class 2


Premarket Reviews
ManufacturerDecision
EARLYSENSE LTD.
  SUBSTANTIALLY EQUIVALENT 3
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
  SUBSTANTIALLY EQUIVALENT 1
PNEUMACARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1


-
-