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FDA 510(k)

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil

K-Number: K163661 · 2018-03-21

Decision Date2018-03-21
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is a medical device manufactured by Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2018-03-21 under approval number K163661. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Rapid Biomedical GmbH. The 510(k) number is K163661.

When was P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil approved by the FDA?

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil received FDA 510(k) clearance on 2018-03-21, under approval number K163661.

What company makes P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is manufactured by Rapid Biomedical GmbH.

What is the FDA product code for P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil?

The FDA product code for P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil is MOS.

Other Devices by Rapid Biomedical GmbH

Related Devices (Code: MOS)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.