OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T— 510(k) K211658
Substantially EquivalentNoras Mri Products GmbH
FDA 510(k) clearance K211658 for OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T, Substantially Equivalent on 2022-03-03. Applicant: Noras Mri Products GmbH. Device class: 2.
Clearance details
- Applicant
- Noras Mri Products GmbH
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hoechberg, DE
Recent devices under product code MOS
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- K262294 — dS FootAnkle 16Ch 1.5T +5 more
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More clearances from Noras Mri Products GmbH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.