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FDA 510(k)

Bleep DreamPort

K-Number: K172335 · 2018-03-30

ApplicantSnapcpap
Decision Date2018-03-30
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Bleep DreamPort is the device name listed in this FDA 510(k) record. The listed applicant is Snapcpap. It received FDA 510(k) clearance on 2018-03-30 under 510(k) number K172335. 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 Bleep DreamPort?

Bleep DreamPort is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Snapcpap. The 510(k) number is K172335.

When did Bleep DreamPort receive FDA 510(k) clearance?

Bleep DreamPort received FDA 510(k) clearance on 2018-03-30, under 510(k) number K172335.

Who is the listed applicant for Bleep DreamPort?

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

What is the FDA product code for Bleep DreamPort?

The FDA product code for Bleep DreamPort is BZD.

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.

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.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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