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FDA 510(k)

TWLIGHT, MODEL ISP 9600

K-Number: K022642 · 2003-02-11

ApplicantInvacare Corp.
Decision Date2003-02-11
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TWLIGHT, MODEL ISP 9600 is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 2003-02-11 under 510(k) number K022642. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWLIGHT, MODEL ISP 9600?

TWLIGHT, MODEL ISP 9600 is a medical device that received FDA 510(k) clearance on 2003-02-11. The listed applicant is Invacare Corp.. The 510(k) number is K022642.

When did TWLIGHT, MODEL ISP 9600 receive FDA 510(k) clearance?

TWLIGHT, MODEL ISP 9600 received FDA 510(k) clearance on 2003-02-11, under 510(k) number K022642.

Who is the listed applicant for TWLIGHT, MODEL ISP 9600?

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

What is the FDA product code for TWLIGHT, MODEL ISP 9600?

The FDA product code for TWLIGHT, MODEL ISP 9600 is BZD.

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Other records listing Invacare Corp. as applicant

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Related Devices (Code: BZD)

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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