LOG-A-RYTHM MODEL 100 AND MODEL 1001— 510(k) K952790

Substantially Equivalent

Nian-Crae, Inc.

FDA 510(k) clearance K952790 for LOG-A-RYTHM MODEL 100 AND MODEL 1001, Substantially Equivalent on 1996-10-17. Applicant: Nian-Crae, Inc..

Clearance details

Applicant: Nian-Crae, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1995-06-19
Decision date: 1996-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, 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.