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BiDop 7 probe PG-30

by Koven Technology, Inc.

BiDop 7 probe PG-30 is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K201114 on 5 Jan 2021 and listed in FDA GUDID since 20 Jan 2021 (UDI-DI 00894912002692), 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) K201114

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 Number00894912002692 UDI-DI Date20 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201114 Date5 Jan 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201114 decided 5 Jan 2021 Active
  • FDA GUDID UDI-DI 00894912002692 listed 20 Jan 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201114
  2. Listed FDA GUDID 00894912002692

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BiDop 7 probe
Generic name
Plethysmography phototransducer
Model / Ref / Catalog
PG-30
Primary DI / UDI-DI
00894912002692
510(k) Number
FDA product code
DPW
GMDN term
Plethysmography phototransducer
Device class
Class II
Regulation number
870.2100
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DPW (Flowmeter, Blood, Cardiovascular).

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See all devices from Koven Technology, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)