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 K982487
Device Name CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
Applicant
Cardiopulmonary Technologies, Inc.
W 260 N 9311 Highway 164
Colgate,  WI  53017 -9600
Applicant Contact MARK S STORSVED
Correspondent
Cardiopulmonary Technologies, Inc.
W 260 N 9311 Highway 164
Colgate,  WI  53017 -9600
Correspondent Contact MARK S STORSVED
Regulation Number868.1880
Classification Product Code
BZC  
Date Received07/17/1998
Decision Date 10/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-