MiniBox

by Pulmone Advanced Medical Devices, Ltd.

MiniBox (PUO-MiniBox) is a Class II device made by Pulmone Advanced Medical Devices, Ltd., cleared under FDA 510(k) K141793 on 6 Mar 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290016675009), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290016675009 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK141793	Date6 Mar 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016675009
FDA 510(k) database 510(k) number K141793

Across registries

2 registries list this device

FDA 510(k) K141793 decided 6 Mar 2015 Active
FDA GUDID UDI-DI 07290016675009 listed 24 Sep 2016 Listed

Timeline

2 dated events

6 Mar 2015 Cleared FDA 510(k) K141793
24 Sep 2016 Listed FDA GUDID 07290016675009

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Pulmonary function analysis system, adult
Model / Ref / Catalog: MiniBox, PUO-MiniBox

Primary DI / UDI-DI: 07290016675009
510(k) Number: K141793
FDA product code: BZC, BZG
GMDN term: Pulmonary function analysis system, adult

Device class: Class II
Regulation number: 868.1880, 868.1840
GUDID distribution status: In Commercial Distribution

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Class II

Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)