BABYTHERM 8004 BABYTHERM 8010— 510(k) K971198

Substantially Equivalent

Drager, Inc.

FDA 510(k) clearance K971198 for BABYTHERM 8004 BABYTHERM 8010, Substantially Equivalent on 1997-10-03. Applicant: Drager, Inc..

Clearance details

Applicant: Drager, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1997-03-31
Decision date: 1997-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.