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FDA 510(k)

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2

K-Number: K131901 · 2013-12-23

Applicant3B Medical, Inc.
Decision Date2013-12-23
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 is the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2013-12-23 under 510(k) number K131901. 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 IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2?

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 is a medical device that received FDA 510(k) clearance on 2013-12-23. The listed applicant is 3B Medical, Inc.. The 510(k) number is K131901.

When did IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 receive FDA 510(k) clearance?

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 received FDA 510(k) clearance on 2013-12-23, under 510(k) number K131901.

Who is the listed applicant for IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2?

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

What is the FDA product code for IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2?

The FDA product code for IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 is BZD.

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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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