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FDA 510(k)

A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I

K-Number: K073134 · 2007-11-16

ApplicantInvacare Corporation
Decision Date2007-11-16
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2007-11-16 under 510(k) number K073134. 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 A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I?

A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I is a medical device that received FDA 510(k) clearance on 2007-11-16. The listed applicant is Invacare Corporation. The 510(k) number is K073134.

When did A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I receive FDA 510(k) clearance?

A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I received FDA 510(k) clearance on 2007-11-16, under 510(k) number K073134.

Who is the listed applicant for A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I?

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

What is the FDA product code for A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I?

The FDA product code for A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I is ITI.

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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

View on FDA Database →

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

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