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FDA 510(k)

RESPCARE HYBRID AV MASK

K-Number: K062224 · 2006-08-17

ApplicantRespcare, Inc.
Decision Date2006-08-17
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPCARE HYBRID AV MASK is the device name listed in this FDA 510(k) record. The listed applicant is Respcare, Inc.. It received FDA 510(k) clearance on 2006-08-17 under 510(k) number K062224. 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 RESPCARE HYBRID AV MASK?

RESPCARE HYBRID AV MASK is a medical device that received FDA 510(k) clearance on 2006-08-17. The listed applicant is Respcare, Inc.. The 510(k) number is K062224.

When did RESPCARE HYBRID AV MASK receive FDA 510(k) clearance?

RESPCARE HYBRID AV MASK received FDA 510(k) clearance on 2006-08-17, under 510(k) number K062224.

Who is the listed applicant for RESPCARE HYBRID AV MASK?

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

What is the FDA product code for RESPCARE HYBRID AV MASK?

The FDA product code for RESPCARE HYBRID AV 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 Respcare, 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.

K052249UTOPIAK052227RESPCARE FACE MASK

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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