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 monitor, breathing frequency
510(k) Number K871813
Device Name VITALOG PMS-8 (MODIFICATION)
Applicant
VITALOG CORP.
643 BAIR ISLAND RD.
SUITE 300
REDWOOD,  CA  94063
Applicant Contact BRUCE RULE
Correspondent
VITALOG CORP.
643 BAIR ISLAND RD.
SUITE 300
REDWOOD,  CA  94063
Correspondent Contact BRUCE RULE
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received05/08/1987
Decision Date 11/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-