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FDA 510(k)

IMASK, MODELS 100, 200 AND 300

K-Number: K051559 · 2005-07-08

ApplicantVital Signs Colorado, Inc.
Decision Date2005-07-08
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IMASK, MODELS 100, 200 AND 300 is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs Colorado, Inc.. It received FDA 510(k) clearance on 2005-07-08 under 510(k) number K051559. 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 IMASK, MODELS 100, 200 AND 300?

IMASK, MODELS 100, 200 AND 300 is a medical device that received FDA 510(k) clearance on 2005-07-08. The listed applicant is Vital Signs Colorado, Inc.. The 510(k) number is K051559.

When did IMASK, MODELS 100, 200 AND 300 receive FDA 510(k) clearance?

IMASK, MODELS 100, 200 AND 300 received FDA 510(k) clearance on 2005-07-08, under 510(k) number K051559.

Who is the listed applicant for IMASK, MODELS 100, 200 AND 300?

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

What is the FDA product code for IMASK, MODELS 100, 200 AND 300?

The FDA product code for IMASK, MODELS 100, 200 AND 300 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

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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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