TR-USB TELEPHONIC STETHOSCOPE


Device Classification Name

stethoscope, electronic

510(k) Number K081032
Device Name TR-USB TELEPHONIC STETHOSCOPE
Applicant
RNK PRODUCTS, INC.
12700 diamond drive
burnsville, 
MN 
55337

Applicant Contact charles r abbruscato
Correspondent
RNK PRODUCTS, INC.
12700 diamond drive
burnsville, 
MN 
55337

Correspodent Contact charles r abbruscato
Regulation Number 870.1875
Classification Product Code
DQD  
Date Received 04/11/2008
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No