ACCUTEMP PROBE— 510(k) K960080

Substantially Equivalent

Kentec Medical, Inc.

FDA 510(k) clearance K960080 for ACCUTEMP PROBE, Substantially Equivalent on 1996-05-01. Applicant: Kentec Medical, Inc..

Clearance details

Applicant: Kentec Medical, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1996-01-11
Decision date: 1996-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.