KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)— 510(k) K964401

Substantially Equivalent

Ludlow Technical Products

FDA 510(k) clearance K964401 for KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4), Substantially Equivalent on 1997-02-06. Applicant: Ludlow Technical Products.

Clearance details

Applicant: Ludlow Technical Products
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1996-11-04
Decision date: 1997-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicopee, MA, 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.