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 Monitor, Breathing Frequency
510(k) Number K151940
Device Name Thora-3Di, Model T-01
Applicant
PneumaCare LIMITED
ST. JOHNS INNOVATION CENTRE, COWLEY ROAD
CAMBRIDGE,  GB CB4 0WS
Applicant Contact MARK HARWOOD
Correspondent
PneumaCare LIMITED
C/O ALACRITA, ONE BROADWAY, 14TH FLOOR, KENDALL SQUARE
CAMBRIDGE,  MA  02142
Correspondent Contact NANDINI MURTHY
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/14/2015
Decision Date 03/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-