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 calculator, pulmonary function data
510(k) Number K133051
Device Name PULMONE MINIBOX PFT TM
Applicant
PULMONE ADVANCED MEDICAL DEVICES, LTD
12154 DARNESTOWN RD, #236
GAITHERSBURG,  MD  20878
Applicant Contact Rhona Shanker
Correspondent
PULMONE ADVANCED MEDICAL DEVICES, LTD
12154 DARNESTOWN RD, #236
GAITHERSBURG,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Code
BZG  
Date Received09/27/2013
Decision Date 05/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01952431
Reviewed by Third Party No
Combination Product No
-
-