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FDA 510(k)

Invacare TDX SP2-HD with Captain's Seat

K-Number: K182946 · 2018-12-11

ApplicantInvacare Corporation
Decision Date2018-12-11
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Invacare TDX SP2-HD with Captain's Seat is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2018-12-11 under 510(k) number K182946. 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 Invacare TDX SP2-HD with Captain's Seat?

Invacare TDX SP2-HD with Captain's Seat is a medical device that received FDA 510(k) clearance on 2018-12-11. The listed applicant is Invacare Corporation. The 510(k) number is K182946.

When did Invacare TDX SP2-HD with Captain's Seat receive FDA 510(k) clearance?

Invacare TDX SP2-HD with Captain's Seat received FDA 510(k) clearance on 2018-12-11, under 510(k) number K182946.

Who is the listed applicant for Invacare TDX SP2-HD with Captain's Seat?

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 Invacare TDX SP2-HD with Captain's Seat?

The FDA product code for Invacare TDX SP2-HD with Captain's Seat is ITI.

Other records listing Invacare Corporation as applicant

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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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