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FDA 510(k)

MEDRAD Imaging Bulk Package Transfer Spike

K-Number: K200280 · 2020-07-30

ApplicantBayer Medical Care, Inc.
Decision Date2020-07-30
Product CodePQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDRAD Imaging Bulk Package Transfer Spike is a medical device manufactured by Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2020-07-30 under approval number K200280. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD Imaging Bulk Package Transfer Spike?

MEDRAD Imaging Bulk Package Transfer Spike is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Bayer Medical Care, Inc.. The 510(k) number is K200280.

When was MEDRAD Imaging Bulk Package Transfer Spike approved by the FDA?

MEDRAD Imaging Bulk Package Transfer Spike received FDA 510(k) clearance on 2020-07-30, under approval number K200280.

What company makes MEDRAD Imaging Bulk Package Transfer Spike?

MEDRAD Imaging Bulk Package Transfer Spike is manufactured by Bayer Medical Care, Inc..

What is the FDA product code for MEDRAD Imaging Bulk Package Transfer Spike?

The FDA product code for MEDRAD Imaging Bulk Package Transfer Spike is PQH.

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Related Devices (Code: PQH)

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Official Source

View on FDA Database →

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

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