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Vista Interface 17001

by Vacumed

Vista Interface 17001 is a Class II device made by Vacumed, cleared under FDA 510(k) K864852 on 4 Mar 1987 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 00850644007084), 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) K864852

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 Number00850644007084 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK864852 Date4 Mar 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K864852 decided 4 Mar 1987 Active
  • FDA GUDID UDI-DI 00850644007084 listed 14 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K864852
  2. Listed FDA GUDID 00850644007084

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vista Interface
Generic name
Cardiopulmonary stress exercise monitoring system
Model / Ref / Catalog
17001
Primary DI / UDI-DI
00850644007084
510(k) Number
FDA product code
BZL
GMDN term
Cardiopulmonary stress exercise monitoring system
Device class
Class II
Regulation number
868.1730
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code BZL (COMPUTER, OXYGEN-UPTAKE).

Other devices from Vacumed

See all devices from Vacumed →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)