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FDA 510(k)

SUMMIT MECHANICAL WHEELCHAIR

K-Number: K946195 · 1995-02-09

ApplicantSummit Durable Medical Equipment, Inc.
Decision Date1995-02-09
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUMMIT MECHANICAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Summit Durable Medical Equipment, Inc.. It received FDA 510(k) clearance on 1995-02-09 under 510(k) number K946195. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUMMIT MECHANICAL WHEELCHAIR?

SUMMIT MECHANICAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Summit Durable Medical Equipment, Inc.. The 510(k) number is K946195.

When did SUMMIT MECHANICAL WHEELCHAIR receive FDA 510(k) clearance?

SUMMIT MECHANICAL WHEELCHAIR received FDA 510(k) clearance on 1995-02-09, under 510(k) number K946195.

Who is the listed applicant for SUMMIT MECHANICAL WHEELCHAIR?

The FDA 510(k) record lists Summit Durable Medical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUMMIT MECHANICAL WHEELCHAIR?

The FDA product code for SUMMIT MECHANICAL WHEELCHAIR is IOR.

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Related Devices (Code: IOR)

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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