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FDA 510(k)

ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.

K-Number: K060657 · 2006-08-18

ApplicantBreas Medical AB
Decision Date2006-08-18
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ISLEEP BY BREAS, MODELS ISLEEP 10, 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 2006-08-18 under 510(k) number K060657. 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 ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.?

ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is Breas Medical AB. The 510(k) number is K060657.

When did ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. receive FDA 510(k) clearance?

ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. received FDA 510(k) clearance on 2006-08-18, under 510(k) number K060657.

Who is the listed applicant for ISLEEP BY BREAS, MODELS ISLEEP 10, 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 ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.?

The FDA product code for ISLEEP BY BREAS, MODELS ISLEEP 10, 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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