RECOMB ECG PREAMPLIFIER/206 069 03— 510(k) K834600

Substantially Equivalent

Litton Medical Electronics

FDA 510(k) clearance K834600 for RECOMB ECG PREAMPLIFIER/206 069 03, Substantially Equivalent on 1984-06-01. Applicant: Litton Medical Electronics.

Clearance details

Applicant: Litton Medical Electronics
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1983-12-30
Decision date: 1984-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.