Babyroo TN300— 510(k) K230278
Substantially EquivalentDraeger Medical Systems, Inc.
FDA 510(k) clearance K230278 for Babyroo TN300, Substantially Equivalent on 2023-05-30. Applicant: Draeger Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Draeger Medical Systems, Inc.
- Product code
- Code FMT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5130
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
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More clearances from Draeger Medical Systems, Inc.
view allAdverse events under product code FMT
product code FMT- Death
- 4
- Malfunction
- 3,074
- Total
- 3,078
Source: openFDA MAUDE database, through . 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.