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FDA 510(k)

ORACLE ORAL MASK

K-Number: K003894 · 2001-06-25

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2001-06-25
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ORACLE ORAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2001-06-25 under 510(k) number K003894. 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 ORACLE ORAL MASK?

ORACLE ORAL MASK is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K003894.

When did ORACLE ORAL MASK receive FDA 510(k) clearance?

ORACLE ORAL MASK received FDA 510(k) clearance on 2001-06-25, under 510(k) number K003894.

Who is the listed applicant for ORACLE ORAL MASK?

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

What is the FDA product code for ORACLE ORAL MASK?

The FDA product code for ORACLE ORAL MASK is BZD.

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Other records listing Fisher & Paykel Healthcare, 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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