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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 a medical device manufactured by Invacare Corporation. It received FDA 510(k) clearance on 2018-12-11 under approval 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. It is manufactured by Invacare Corporation. The 510(k) number is K182946.

When was Invacare TDX SP2-HD with Captain's Seat approved by the FDA?

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

What company makes Invacare TDX SP2-HD with Captain's Seat?

Invacare TDX SP2-HD with Captain's Seat is manufactured by Invacare Corporation.

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.

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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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