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FDA 510(k)

BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003

K-Number: K061099 · 2006-08-11

ApplicantHoffman Laboratories, LLC
Decision Date2006-08-11
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 is the device name listed in this FDA 510(k) record. The listed applicant is Hoffman Laboratories, LLC. It received FDA 510(k) clearance on 2006-08-11 under 510(k) number K061099. 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 BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003?

BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 is a medical device that received FDA 510(k) clearance on 2006-08-11. The listed applicant is Hoffman Laboratories, LLC. The 510(k) number is K061099.

When did BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 receive FDA 510(k) clearance?

BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 received FDA 510(k) clearance on 2006-08-11, under 510(k) number K061099.

Who is the listed applicant for BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003?

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

What is the FDA product code for BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003?

The FDA product code for BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 is BZD.

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Other records listing Hoffman Laboratories, LLC 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.

K052597BREATHEX OMEGA CPAP DEVICE, MODEL 322

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

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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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