ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE— 510(k) K912742

Substantially Equivalent

Spacelabs, Inc.

FDA 510(k) clearance K912742 for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE, Substantially Equivalent on 1992-04-20. Applicant: Spacelabs, Inc..

Clearance details

Applicant: Spacelabs, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1991-06-21
Decision date: 1992-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, 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.