FDA 510(k) Application Details - K974208

Device Classification Name	Device, Temperature Measurement, Direct Contact, Powered   More FDA Info for this Device
510(K) Number	K974208
Device Name	Device, Temperature Measurement, Direct Contact, Powered
Applicant	TITRONICS RESEARCH & DEVELOPMENT CO. 2046 REDWING HOLLOW S.W. OXFORD, IA 52322 US Other 510(k) Applications for this Company
Contact	JOSEPH R TITONE Other 510(k) Applications for this Contact
Regulation Number	882.1570   More FDA Info for this Regulation Number
Classification Product Code	HCS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/1997
Decision Date	02/03/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review