Natus Quantum— 510(k) K143440
Substantially EquivalentNatus Medical Incorporated
FDA 510(k) clearance K143440 for Natus Quantum, Substantially Equivalent on 2015-04-20. Applicant: Natus Medical Incorporated. Device class: 2.
Clearance details
- Applicant
- Natus Medical Incorporated
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakville, CA
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Recalls naming K143440
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143440.
Data sourced from openFDA. This site is unofficial and independent of the FDA.