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 ventilatory effort recorder
510(k) Number K000396
Device Name APNOESCREEN PRO, ALPHA SCREEN PRO
Applicant
ERICH JAEGER, INC.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact LARRY MURDOCK
Correspondent
ERICH JAEGER, INC.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Correspondent Contact LARRY MURDOCK
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/07/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-