SURFACE TEMPERATURE PROBES— 510(k) K943270

Substantially Equivalent

Coast Medical, Inc.

FDA 510(k) clearance K943270 for SURFACE TEMPERATURE PROBES, Substantially Equivalent on 1994-12-05. Applicant: Coast Medical, Inc..

Clearance details

Applicant: Coast Medical, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1994-07-07
Decision date: 1994-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, 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.