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RNK Products PCP-USB

by Rnk Products, Inc.

RNK Products PCP-USB is a Class II device made by Rnk Products, Inc., cleared under FDA 510(k) K132560 on 11 Oct 2013 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00677986002023), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K132560

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00677986002023 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132560 Date11 Oct 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132560 decided 11 Oct 2013 Active
  • FDA GUDID UDI-DI 00677986002023 listed 31 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132560
  2. Listed FDA GUDID 00677986002023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RNK Products
Generic name
Electronic acoustic stethoscope
Model / reference
PCP-USB
Primary DI / UDI-DI
00677986002023
510(k) Number
FDA product code
DQD
GMDN term
Electronic acoustic stethoscope
Device class
Class II
Regulation number
870.1875
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)