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 amplifier and signal conditioner, transducer signal
Regulation Description Transducer signal amplifier and conditioner.
Product CodeDRQ
Regulation Number 870.2060
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device Operates Differently Than Expected 3
Electrical Power Problem 1
Amplifier 1
Total Device Problems 5

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jun-18-2015

-
-