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 Plethysmograph, Volume
510(k) Number K951901
Device Name MASTERSCREEN PFT BODY
Applicant
Erich Jaeger GmbH & Co. KG
Leibnizstrasse 7
Hoechberg,  DE D-97204
Applicant Contact DETLEF GROTHEER
Correspondent
Erich Jaeger GmbH & Co. KG
Leibnizstrasse 7
Hoechberg,  DE D-97204
Correspondent Contact DETLEF GROTHEER
Regulation Number868.1760
Classification Product Code
JEH  
Date Received04/24/1995
Decision Date 07/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-