TELEMETRY SYSTEM, BIOTEL 300— 510(k) K781836

Substantially Equivalent

Spacelabs, Inc.

FDA 510(k) clearance K781836 for TELEMETRY SYSTEM, BIOTEL 300, Substantially Equivalent on 1978-12-04. Applicant: Spacelabs, Inc..

Clearance details

Applicant: Spacelabs, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 1978-10-30
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.