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FDA 510(k)

HUMIDIFIER & ACCESSORIES

K-Number: K953949 · 1995-10-16

ApplicantFisher & Paykel Electronics , Ltd.
Decision Date1995-10-16
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMIDIFIER & ACCESSORIES 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 1995-10-16 under 510(k) number K953949. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMIDIFIER & ACCESSORIES?

HUMIDIFIER & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Fisher & Paykel Electronics , Ltd.. The 510(k) number is K953949.

When did HUMIDIFIER & ACCESSORIES receive FDA 510(k) clearance?

HUMIDIFIER & ACCESSORIES received FDA 510(k) clearance on 1995-10-16, under 510(k) number K953949.

Who is the listed applicant for HUMIDIFIER & ACCESSORIES?

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 HUMIDIFIER & ACCESSORIES?

The FDA product code for HUMIDIFIER & ACCESSORIES is CAW.

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Other records listing Fisher & Paykel Electronics , Ltd. 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.

K973161CPAP HUMIDIFIER (HC 200)K972885SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970K971695SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMERK971461SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)K970432INFANT RADIANT WARMER - MODELS IW910 AND IW920K953392HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)

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Related Devices (Code: CAW)

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.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC

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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