LULLABY— 510(k) K071828
Substantially EquivalentGe Healthcare Clinical Systems
FDA 510(k) clearance K071828 for LULLABY, Substantially Equivalent on 2007-08-06. Applicant: Ge Healthcare Clinical Systems. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare Clinical Systems
- Product code
- Code LBI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5700
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laurel, MD, US
Recent devices under product code LBI
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