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FDA 510(k)

H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP

K-Number: K871351 · 1987-05-14

ApplicantHolter-Hausner Intl.
Decision Date1987-05-14
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1987-05-14 under 510(k) number K871351. 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 H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP?

H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP is a medical device that received FDA 510(k) clearance on 1987-05-14. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K871351.

When did H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP receive FDA 510(k) clearance?

H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP received FDA 510(k) clearance on 1987-05-14, under 510(k) number K871351.

Who is the listed applicant for H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP?

The FDA 510(k) record lists Holter-Hausner Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP?

The FDA product code for H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP is BZD.

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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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