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FDA 510(k)

CPAP HUMIDIFIER (HC 200)

K-Number: K973161 · 1998-07-10

ApplicantFisher & Paykel Electronics , Ltd.
Decision Date1998-07-10
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPAP HUMIDIFIER (HC 200) is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Electronics , Ltd.. It received FDA 510(k) clearance on 1998-07-10 under 510(k) number K973161. 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 CPAP HUMIDIFIER (HC 200)?

CPAP HUMIDIFIER (HC 200) is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Fisher & Paykel Electronics , Ltd.. The 510(k) number is K973161.

When did CPAP HUMIDIFIER (HC 200) receive FDA 510(k) clearance?

CPAP HUMIDIFIER (HC 200) received FDA 510(k) clearance on 1998-07-10, under 510(k) number K973161.

Who is the listed applicant for CPAP HUMIDIFIER (HC 200)?

The FDA 510(k) record lists Fisher & Paykel Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPAP HUMIDIFIER (HC 200)?

The FDA product code for CPAP HUMIDIFIER (HC 200) is BZD.

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Other records listing Fisher & Paykel Electronics , Ltd. 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.

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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