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PAHI VersalVent Model V1

by Pan-America Hyperbarics, Inc.

PAHI VersalVent Model V1 is a Class II device made by Pan-America Hyperbarics, Inc., cleared under FDA 510(k) K122560 on 26 Mar 2013 and listed in FDA GUDID since 10 Oct 2015 (UDI-DI 04719872000006), 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) K122560

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 Number04719872000006 UDI-DI Date10 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122560 Date26 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122560 decided 26 Mar 2013 Active
  • FDA GUDID UDI-DI 04719872000006 listed 10 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122560
  2. Listed FDA GUDID 04719872000006

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PAHI VersalVent
Generic name
Portable pneumatic ventilator
Model / reference
Model V1
Primary DI / UDI-DI
04719872000006
510(k) Number
FDA product code
CBK
GMDN term
Portable pneumatic ventilator
Device class
Class II
Regulation number
868.5895
GUDID distribution status
In Commercial Distribution
Size
Height — 241.3 Millimeter
Width — 203.2 Millimeter
Length — 304.8 Millimeter

Similar devices

Other devices filed under FDA product code CBK (Ventilator, Continuous, Facility Use).

Other devices from Pan-America Hyperbarics, Inc.

See all devices from Pan-America Hyperbarics, Inc. →

Properties

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