ZOMED PASSIVE TEMPERATURE PROBE— 510(k) K964286

Substantially Equivalent

Zomed Intl.

FDA 510(k) clearance K964286 for ZOMED PASSIVE TEMPERATURE PROBE, Substantially Equivalent on 1996-11-19. Applicant: Zomed Intl..

Clearance details

Applicant: Zomed Intl.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1996-10-28
Decision date: 1996-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.