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FDA 510(k)

SPEED SHIFT

K-Number: K124022 · 2013-05-14

ApplicantBiomedical Enterprises, Inc.
Decision Date2013-05-14
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPEED SHIFT is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Enterprises, Inc.. It received FDA 510(k) clearance on 2013-05-14 under 510(k) number K124022. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEED SHIFT?

SPEED SHIFT is a medical device that received FDA 510(k) clearance on 2013-05-14. The listed applicant is Biomedical Enterprises, Inc.. The 510(k) number is K124022.

When did SPEED SHIFT receive FDA 510(k) clearance?

SPEED SHIFT received FDA 510(k) clearance on 2013-05-14, under 510(k) number K124022.

Who is the listed applicant for SPEED SHIFT?

The FDA 510(k) record lists Biomedical Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPEED SHIFT?

The FDA product code for SPEED SHIFT is JDR.

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Other records listing Biomedical Enterprises, Inc. as applicant

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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.

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