ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE— 510(k) K950143

Substantially Equivalent

Astral, Ltd.

FDA 510(k) clearance K950143 for ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE, Substantially Equivalent on 1995-09-25. Applicant: Astral, Ltd..

Clearance details

Applicant: Astral, Ltd.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1995-01-13
Decision date: 1995-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millersville, MD, 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.