Skip to content

Digital Mxr-D Flowmeter

by Porter Instrument Co., Inc.

510(k) K062155

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062155 Date9 Nov 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0228-2009 FDA Unclassified (pre-2012) initiated 26 Aug 2008 on shared 510(k) K062155

    inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
BSZ
Device Class
Class II
Regulation
21 CFR Part 868.5160
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Porter Instrument Co., Inc.