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PFT Kit E, VBMax36E - 189139

by A-M Systems, LLC

PFT Kit E, VBMax36E - 189139 is a pulmonary function testing kit (FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by A-M Systems, LLC, cleared under FDA 510(k) K000654 on 14 Nov 2000 and listed in FDA GUDID since 25 Feb 2025 (UDI-DI 00817081028263), 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) K000654

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 Number00817081028263 UDI-DI Date25 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK000654 Date14 Nov 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000654 decided 14 Nov 2000 Active
  • FDA GUDID UDI-DI 00817081028263 listed 25 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000654
  2. Listed FDA GUDID 00817081028263

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PFT Kit E, VBMax36E
Generic name
Pulmonary function testing kit
Model / Ref / Catalog
PFT Kit E, VBMax36E - 189139, 189139
Primary DI / UDI-DI
00817081028263
510(k) Number
FDA product code
CAH
GMDN term
Pulmonary function testing kit
Device class
Class II
Regulation number
868.5260
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary function testing kit

Cleared under the same submission (K000654)

and 8 more cleared under K000654

Similar devices

Other devices filed under FDA product code CAH (Filter, Bacterial, Breathing-Circuit).

Other devices from A-M Systems, Inc.

See all devices from A-M Systems, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)