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Finapres Nova Scope PC

by Finapres Medical Systems B.V.

Finapres Nova Scope PC (FP_910641) is a Class II device made by Finapres Medical Systems B.V., cleared under FDA 510(k) K141460 on 20 Mar 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08719327003756), active as of 23 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 23 Oct 2026

Documents

510(k) K141460

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08719327003756 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141460 Date20 Mar 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141460 decided 20 Mar 2015 Active
  • FDA GUDID UDI-DI 08719327003756 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141460
  2. Listed FDA GUDID 08719327003756

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Finapres
Generic name
Patient monitoring system module, blood pressure, noninvasive
Model / Ref / Catalog
Nova Scope PC, FP_910641
Primary DI / UDI-DI
08719327003756
510(k) Number
FDA product code
DXN
GMDN term
Patient monitoring system module, blood pressure, noninvasive
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

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Properties

Other properties (15, all answered No)