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FDA 510(k)

OVERLANDER PEV 2000

K-Number: K983497 · 1999-06-27

ApplicantRaye'S, Inc.
Decision Date1999-06-27
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OVERLANDER PEV 2000 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 1999-06-27 under 510(k) number K983497. 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 OVERLANDER PEV 2000?

OVERLANDER PEV 2000 is a medical device that received FDA 510(k) clearance on 1999-06-27. The listed applicant is Raye'S, Inc.. The 510(k) number is K983497.

When did OVERLANDER PEV 2000 receive FDA 510(k) clearance?

OVERLANDER PEV 2000 received FDA 510(k) clearance on 1999-06-27, under 510(k) number K983497.

Who is the listed applicant for OVERLANDER PEV 2000?

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 OVERLANDER PEV 2000?

The FDA product code for OVERLANDER PEV 2000 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 CHAIRK002580PRAIRIE CRUISER

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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