FDA 510(k) Application Details - K980157

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K980157
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	USA INSTRUMENTS, INC. 675-B ALPHA DR. HIGHLAND HEIGHTS, OH 44143 US Other 510(k) Applications for this Company
Contact	RONY THOMAS Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	MOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1998
Decision Date	04/13/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review