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EasyOne Pro LAB 3100-1

by NDD Medizintechnik AG

EasyOne Pro LAB 3100-1 is a pulmonary function analysis system (FDA Class II; FDA product code BTY, Calculator, Predicted Values, Pulmonary Function) made by NDD Medizintechnik AG, cleared under FDA 510(k) K120635 on 27 Sep 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07640142190370), 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) K120635

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 Number07640142190370 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120635 Date27 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120635 decided 27 Sep 2012 Active
  • FDA GUDID UDI-DI 07640142190370 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120635
  2. Listed FDA GUDID 07640142190370

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EasyOne Pro LAB
Generic name
Pulmonary function analysis system, adult
Model / Ref / Catalog
3100-1
Primary DI / UDI-DI
07640142190370
510(k) Number
FDA product code
BTY
GMDN term
Pulmonary function analysis system, adult
Device class
Class II
Regulation number
868.1890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary function analysis system, adult

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Other devices filed under Pulmonary function analysis system, adult.

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Properties

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