FLEXIBLE CARDIAC COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K110487
Device Name FLEXIBLE CARDIAC COIL
Applicant
LBDS HOLDING COMPANY
6440 sky pointe dr
suite 140
las vegas, 
NV 
89131

Applicant Contact richard bryant
Correspondent
LBDS HOLDING COMPANY
6440 sky pointe dr
suite 140
las vegas, 
NV 
89131

Correspodent Contact richard bryant
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 02/22/2011
Decision Date 04/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No