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 stimulator, nerve, battery-powered
510(k) Number K892396
Device Name MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR
Applicant
BIOMETER INTL. A/S
21 A/ HANS EGEDESVEJ
DK- - 5210 ODENSE NV
DENMARK,  DK
Applicant Contact FLEMMING HIMMELSTRUP
Correspondent
BIOMETER INTL. A/S
21 A/ HANS EGEDESVEJ
DK- - 5210 ODENSE NV
DENMARK,  DK
Correspondent Contact FLEMMING HIMMELSTRUP
Regulation Number868.2775
Classification Product Code
BXN  
Date Received04/07/1989
Decision Date 10/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-