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FDA 510(k)

BESTFIT2 NASAL MASK

K-Number: K130663 · 2013-09-27

ApplicantCurative Medical, Inc.
Decision Date2013-09-27
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BESTFIT2 NASAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Curative Medical, Inc.. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K130663. 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 BESTFIT2 NASAL MASK?

BESTFIT2 NASAL MASK is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Curative Medical, Inc.. The 510(k) number is K130663.

When did BESTFIT2 NASAL MASK receive FDA 510(k) clearance?

BESTFIT2 NASAL MASK received FDA 510(k) clearance on 2013-09-27, under 510(k) number K130663.

Who is the listed applicant for BESTFIT2 NASAL MASK?

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

What is the FDA product code for BESTFIT2 NASAL MASK?

The FDA product code for BESTFIT2 NASAL MASK is BZD.

Related Clinical Trials

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.

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Other records listing Curative Medical, Inc. 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.

K131702K SERIES CPAP SYSTEMSK123897K SERIES CPAP SYSTEMSK120285K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER

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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