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Henry Schein 5700683

by Henry Schein, Inc.

Henry Schein 5700683 is a diagnostic spirometer (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Henry Schein, Inc., cleared under FDA 510(k) K161536 on 5 Jan 2017 and listed in FDA GUDID since 26 Dec 2017 (UDI-DI 00304040061954), 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) K161536

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 Number00304040061954 UDI-DI Date26 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161536 Date5 Jan 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161536 decided 5 Jan 2017 Active
  • FDA GUDID UDI-DI 00304040061954 listed 26 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161536
  2. Listed FDA GUDID 00304040061954

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Henry Schein
Generic name
Diagnostic spirometer, professional
Model / Ref / Catalog
5700683
Primary DI / UDI-DI
00304040061954
510(k) Number
FDA product code
BZG
GMDN term
Diagnostic spirometer, professional
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution

Related devices

Category: Diagnostic spirometer, professional

Cleared under the same submission (K161536)

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)