HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K110752
Device Name HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
Applicant
HIGHLAND INSTRUMENTS
755 westminster street
unit 120
providence, 
RI 
02903

Applicant Contact leo basta
Correspondent
HIGHLAND INSTRUMENTS
755 westminster street
unit 120
providence, 
RI 
02903

Correspodent Contact leo basta
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Code
BWN  
Date Received 03/18/2011
Decision Date 06/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No