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FDA 510(k)

PRAIRIE CRUISER

K-Number: K002580 · 2001-07-03

ApplicantRaye'S, Inc.
Decision Date2001-07-03
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRAIRIE CRUISER is the device name listed in this FDA 510(k) record. The listed applicant is Raye'S, Inc.. It received FDA 510(k) clearance on 2001-07-03 under 510(k) number K002580. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRAIRIE CRUISER?

PRAIRIE CRUISER is a medical device that received FDA 510(k) clearance on 2001-07-03. The listed applicant is Raye'S, Inc.. The 510(k) number is K002580.

When did PRAIRIE CRUISER receive FDA 510(k) clearance?

PRAIRIE CRUISER received FDA 510(k) clearance on 2001-07-03, under 510(k) number K002580.

Who is the listed applicant for PRAIRIE CRUISER?

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

What is the FDA product code for PRAIRIE CRUISER?

The FDA product code for PRAIRIE CRUISER is ITI.

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 Raye'S, 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.

K022407MULTI FUCTIONAL REHABILITATION CHAIRK983497OVERLANDER PEV 2000

Related Devices (Code: ITI)

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

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