SURETEMP— 510(k) K964643

Substantially Equivalent

Diatek Instruments, Inc.

FDA 510(k) clearance K964643 for SURETEMP, Substantially Equivalent on 1997-01-09. Applicant: Diatek Instruments, Inc..

Clearance details

Applicant: Diatek Instruments, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1996-11-12
Decision date: 1997-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.