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FDA 510(k)

INVACARE PASSOVER HUMIDIFIER MODEL ISP9700

K-Number: K003561 · 2001-04-17

ApplicantInvacare Corp.
Decision Date2001-04-17
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 2001-04-17 under 510(k) number K003561. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVACARE PASSOVER HUMIDIFIER MODEL ISP9700?

INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 is a medical device that received FDA 510(k) clearance on 2001-04-17. The listed applicant is Invacare Corp.. The 510(k) number is K003561.

When did INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 receive FDA 510(k) clearance?

INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 received FDA 510(k) clearance on 2001-04-17, under 510(k) number K003561.

Who is the listed applicant for INVACARE PASSOVER HUMIDIFIER MODEL ISP9700?

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 INVACARE PASSOVER HUMIDIFIER MODEL ISP9700?

The FDA product code for INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 is BTT.

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Other records listing Invacare Corp. as applicant

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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Related Devices (Code: BTT)

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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