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FDA 510(k)

INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

K-Number: K031176 · 2004-03-25

ApplicantInvacare Corp.
Decision Date2004-03-25
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 2004-03-25 under 510(k) number K031176. 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 POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000?

INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 is a medical device that received FDA 510(k) clearance on 2004-03-25. The listed applicant is Invacare Corp.. The 510(k) number is K031176.

When did INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 receive FDA 510(k) clearance?

INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 received FDA 510(k) clearance on 2004-03-25, under 510(k) number K031176.

Who is the listed applicant for INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000?

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 POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000?

The FDA product code for INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 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.

K071928THE INVACARE FLYER, MODEL IPC 100K070321TWILIGHT FULL FACE MASKK062402EASYSTAND EVOLVK061874INVACARE'S TWILIGHT II NASAL MASKSK033819INVACARE 3G TARSYSK031064INVACARE POLARIS EX CPAP, MODEL ISP3000

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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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