QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K050088
Device Name QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
Applicant
NEOPROBE CORP.
425 metro place north,
ste. 300
dublin, 
OH 
43017

Applicant Contact rodger a brown
Correspondent
NEOPROBE CORP.
425 metro place north,
ste. 300
dublin, 
OH 
43017

Correspodent Contact rodger a brown
Regulation Number 870.2100
Classification Product Code
DPW  
Date Received 01/13/2005
Decision Date 02/08/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No