PULSE CARDULE (MODEL 1859/1860 ECG)— 510(k) K760120

Substantially Equivalent

Spacelabs, Inc.

FDA 510(k) clearance K760120 for PULSE CARDULE (MODEL 1859/1860 ECG), Substantially Equivalent on 1976-07-20. Applicant: Spacelabs, Inc..

Clearance details

Applicant: Spacelabs, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1976-06-28
Decision date: 1976-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.