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 System, Breath Measurement
510(k) Number K882499
Device Name JAYCO HYDROGEN MONITOR
Applicant
Enteron, Inc.
895 Poplar Church Rd.
Camp Hill,  PA  17011
Applicant Contact SUSAN P BJORKMAN
Correspondent
Enteron, Inc.
895 Poplar Church Rd.
Camp Hill,  PA  17011
Correspondent Contact SUSAN P BJORKMAN
Regulation Number862.1820
Classification Product Code
NRH  
Date Received06/17/1988
Decision Date 06/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-