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FDA 510(k)

BREAS PV 10I CPAP SYSTEM, MODEL PV 10I

K-Number: K030985 · 2003-10-15

ApplicantVital Signs, Inc.
Decision Date2003-10-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREAS PV 10I CPAP SYSTEM, MODEL PV 10I is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K030985. 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 BREAS PV 10I CPAP SYSTEM, MODEL PV 10I?

BREAS PV 10I CPAP SYSTEM, MODEL PV 10I is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Vital Signs, Inc.. The 510(k) number is K030985.

When did BREAS PV 10I CPAP SYSTEM, MODEL PV 10I receive FDA 510(k) clearance?

BREAS PV 10I CPAP SYSTEM, MODEL PV 10I received FDA 510(k) clearance on 2003-10-15, under 510(k) number K030985.

Who is the listed applicant for BREAS PV 10I CPAP SYSTEM, MODEL PV 10I?

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

What is the FDA product code for BREAS PV 10I CPAP SYSTEM, MODEL PV 10I?

The FDA product code for BREAS PV 10I CPAP SYSTEM, MODEL PV 10I is BZD.

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Other records listing Vital Signs, Inc. as applicant

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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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