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FDA 510(k)

FREERIDER, MODEL FR510-F

K-Number: K971387 · 1997-07-23

ApplicantFreerider USA, Inc.
Decision Date1997-07-23
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FREERIDER, MODEL FR510-F is the device name listed in this FDA 510(k) record. The listed applicant is Freerider USA, Inc.. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K971387. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREERIDER, MODEL FR510-F?

FREERIDER, MODEL FR510-F is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Freerider USA, Inc.. The 510(k) number is K971387.

When did FREERIDER, MODEL FR510-F receive FDA 510(k) clearance?

FREERIDER, MODEL FR510-F received FDA 510(k) clearance on 1997-07-23, under 510(k) number K971387.

Who is the listed applicant for FREERIDER, MODEL FR510-F?

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

What is the FDA product code for FREERIDER, MODEL FR510-F?

The FDA product code for FREERIDER, MODEL FR510-F is INI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Freerider USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971388FREERIDER, MODEL FR168-4

Related Devices (Code: INI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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