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Jdm SP2 Sensor

by Jd Monitoring C/O Mackler, Cooper and Gibbs

510(k) K873806

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK873806 Date8 Dec 1987ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1945-2010 FDA Unclassified (pre-2012) initiated 26 Mar 2010
    • Terminated Z-1947-2010 FDA Unclassified (pre-2012) initiated 26 Mar 2010
    • Terminated Z-1946-2010 FDA Unclassified (pre-2012) initiated 26 Mar 2010
    • Terminated Z-1944-2010 FDA Unclassified (pre-2012) initiated 26 Mar 2010

    Product might not indicate low battery alarms or exit alarms when powered by a DC power supply.

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  • Withdrawn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
KMI
Device Class
Class I
Regulation
21 CFR Part 880.2400
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent