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Av 800 Ventilator

by Penlon, Ltd.

510(k) K010317

Av 800 Ventilator is a medical device (FDA Class II; FDA product code CBK, Ventilator, Continuous, Facility Use) made by Penlon, Ltd., cleared under FDA 510(k) K010317 on 23 Jul 2001, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010317 Date23 Jul 2001ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
CBK
FDA applicant
Penlon , Ltd.
Device class
Class II
Regulation
21 CFR Part 868.5895
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Similar devices

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

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