LULLABY TM WARMER— 510(k) K121625

Name: FDA 510(k) clearance K121625
Creator: U.S. Food and Drug Administration
Published: 2012-09-14

Substantially Equivalent

Wipro GE Healthcare Private, Ltd.

FDA 510(k) clearance K121625 for LULLABY TM WARMER, Substantially Equivalent on 2012-09-14. Applicant: Wipro GE Healthcare Private, Ltd.. Device class: 2.

Clearance details

Applicant: Wipro GE Healthcare Private, Ltd.
Product code: Code FMT
Device class: Class 2
Regulation: 21 CFR 880.5130
Advisory panel: General Hospital
Date received: 2012-06-01
Decision date: 2012-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laurel, MD, US

Download summary PDF View on FDA.gov ↗

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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.