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FDA 510(k)

3B WILLOW

K-Number: K112271 · 2012-02-16

Applicant3B Products, LLC
Decision Date2012-02-16
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

3B WILLOW is the device name listed in this FDA 510(k) record. The listed applicant is 3B Products, LLC. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K112271. 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 3B WILLOW?

3B WILLOW is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is 3B Products, LLC. The 510(k) number is K112271.

When did 3B WILLOW receive FDA 510(k) clearance?

3B WILLOW received FDA 510(k) clearance on 2012-02-16, under 510(k) number K112271.

Who is the listed applicant for 3B WILLOW?

The FDA 510(k) record lists 3B Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3B WILLOW?

The FDA product code for 3B WILLOW is BZD.

Related Clinical Trials

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Other records listing 3B Products, 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.

K1034343B FLEX-LITE

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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