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FDA 510(k)

BREAS ISLEEP 20+

K-Number: K061057 · 2006-06-23

ApplicantBreas Medical AB
Decision Date2006-06-23
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREAS ISLEEP 20+ is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K061057. 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 BREAS ISLEEP 20+?

BREAS ISLEEP 20+ is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Breas Medical AB. The 510(k) number is K061057.

When did BREAS ISLEEP 20+ receive FDA 510(k) clearance?

BREAS ISLEEP 20+ received FDA 510(k) clearance on 2006-06-23, under 510(k) number K061057.

Who is the listed applicant for BREAS ISLEEP 20+?

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

What is the FDA product code for BREAS ISLEEP 20+?

The FDA product code for BREAS ISLEEP 20+ is BZD.

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Other records listing Breas Medical AB 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.

K242485EveryWareK242438ClearoK233452Vivo 45 LSK240779Vivo 3K240778Vivo 1, Vivo 2K193586Vivo 45 LS

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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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