I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016


Device Classification Name

probe, blood-flow, extravascular

510(k) Number K073593
Device Name I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
Applicant
DELTEX MEDICAL LIMITED
business & technology center/
bessemer drive
stevenage, hertfordshire, 

GB

sg1 2dx

Applicant Contact neil r armstrong
Correspondent
DELTEX MEDICAL LIMITED
business & technology center/
bessemer drive
stevenage, hertfordshire, 

GB

sg1 2dx

Correspodent Contact neil r armstrong
Regulation Number 870.2120
Classification Product Code
DPT  
Date Received 12/21/2007
Decision Date 01/29/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No