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FDA 510(k)

VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES

K-Number: K082630 · 2008-12-19

ApplicantZefon Intl.
Decision Date2008-12-19
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Zefon Intl.. It received FDA 510(k) clearance on 2008-12-19 under 510(k) number K082630. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES?

VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES is a medical device that received FDA 510(k) clearance on 2008-12-19. The listed applicant is Zefon Intl.. The 510(k) number is K082630.

When did VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES receive FDA 510(k) clearance?

VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES received FDA 510(k) clearance on 2008-12-19, under 510(k) number K082630.

Who is the listed applicant for VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES?

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

What is the FDA product code for VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES?

The FDA product code for VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES is DXQ.

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 Zefon Intl. 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.

K080366DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES

Related Devices (Code: DXQ)

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.

K254287Medline Reusable Blood Pressure CuffMedline Industries, LPK260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden CorporationK253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc.K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare CorporationK250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation

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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