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FDA 510(k)

WHEELCHAIR, MECHANICAL

K-Number: K850064 · 1985-04-04

ApplicantComaco, Inc.
Decision Date1985-04-04
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WHEELCHAIR, MECHANICAL is the device name listed in this FDA 510(k) record. The listed applicant is Comaco, Inc.. It received FDA 510(k) clearance on 1985-04-04 under 510(k) number K850064. 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 WHEELCHAIR, MECHANICAL?

WHEELCHAIR, MECHANICAL is a medical device that received FDA 510(k) clearance on 1985-04-04. The listed applicant is Comaco, Inc.. The 510(k) number is K850064.

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

WHEELCHAIR, MECHANICAL received FDA 510(k) clearance on 1985-04-04, under 510(k) number K850064.

Who is the listed applicant for WHEELCHAIR, MECHANICAL?

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

What is the FDA product code for WHEELCHAIR, MECHANICAL?

The FDA product code for WHEELCHAIR, MECHANICAL is IOR.

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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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