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Performer Cbp System

by Rand S.R.L.

510(k) K070213

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 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070213 Date21 Mar 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1090-2007 FDA Unclassified (pre-2012) initiated 4 Jun 2007

    Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))

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  • Withdrawn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
DTQ
Device Class
Class II
Regulation
21 CFR Part 870.4220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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