510(k) K034046

RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 by Rnk Products — Product Code DQD

K034046 is an FDA 510(k) premarket notification submitted by Rnk Products for the device "RNK TELEPHONIC STETHOSCOPE, MODEL TR-1". The FDA issued a decision of Substantially Equivalent on March 10, 2004. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Rnk Products has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2004
Date Received
December 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Electronic
Device Class
Class II
Regulation Number
870.1875
Review Panel
CV
Submission Type