FDA 510(k) Application Details - K122897

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K122897
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	INVIVO CORPORATION 3545 SW 47TH AVE GAINESVILLE, FL 32608 US Other 510(k) Applications for this Company
Contact	LANCE AULABAUGH 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	09/21/2012
Decision Date	12/21/2012
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