MCINTOSH, MILLER, FOREGGER BABY— 510(k) K945425

Substantially Equivalent

Rudolf Riester GmbH & Co. KG

FDA 510(k) clearance K945425 for MCINTOSH, MILLER, FOREGGER BABY, Substantially Equivalent on 1995-03-20. Applicant: Rudolf Riester GmbH & Co. KG.

Clearance details

Applicant: Rudolf Riester GmbH & Co. KG
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1994-11-04
Decision date: 1995-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: D-72417 Jungingen, DE

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Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.