PCP-USB STETHOSCOPE

Stethoscope, Electronic

RNK PRODUCTS, INC.

The following data is part of a premarket notification filed by Rnk Products, Inc. with the FDA for Pcp-usb Stethoscope.

Pre-market Notification Details

Device IDK132560
510k NumberK132560
Device Name:PCP-USB STETHOSCOPE
ClassificationStethoscope, Electronic
Applicant RNK PRODUCTS, INC. 8247 Devereux Dr Ste 101 Melbourne,  FL  32940
ContactCharles R Abbruscato
CorrespondentCharles R Abbruscato
RNK PRODUCTS, INC. 8247 Devereux Dr Ste 101 Melbourne,  FL  32940
Product CodeDQD  
CFR Regulation Number870.1875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-15
Decision Date2013-10-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00677994002022 K132560 000
00677986002023 K132560 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.