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FDA 510(k)

INVACARE POLARIS EX CPAP, MODEL ISP3000

K-Number: K031064 · 2004-03-12

ApplicantInvacare Corp.
Decision Date2004-03-12
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INVACARE POLARIS EX CPAP, MODEL ISP3000 is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 2004-03-12 under 510(k) number K031064. 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 INVACARE POLARIS EX CPAP, MODEL ISP3000?

INVACARE POLARIS EX CPAP, MODEL ISP3000 is a medical device that received FDA 510(k) clearance on 2004-03-12. The listed applicant is Invacare Corp.. The 510(k) number is K031064.

When did INVACARE POLARIS EX CPAP, MODEL ISP3000 receive FDA 510(k) clearance?

INVACARE POLARIS EX CPAP, MODEL ISP3000 received FDA 510(k) clearance on 2004-03-12, under 510(k) number K031064.

Who is the listed applicant for INVACARE POLARIS EX CPAP, MODEL ISP3000?

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 CPAP, MODEL ISP3000?

The FDA product code for INVACARE POLARIS EX CPAP, MODEL ISP3000 is BZD.

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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 TARSYSK031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

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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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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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