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 Meter, Peak Flow, Spirometry
510(k) Number K955262
Device Name TRUZONE PEAK FLOW METER
Applicant
MONAGHAN MEDICAL CORP.
5 LATOUR AVE., SUITE 1600
PLATTSBURGH,  NY  12901
Applicant Contact JAMES A COCHIE
Correspondent
MONAGHAN MEDICAL CORP.
5 LATOUR AVE., SUITE 1600
PLATTSBURGH,  NY  12901
Correspondent Contact JAMES A COCHIE
Regulation Number868.1860
Classification Product Code
BZH  
Date Received11/14/1995
Decision Date 03/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-