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FDA 510(k)

ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II

K-Number: K053006 · 2006-02-03

ApplicantRossmax Internationl , Ltd.
Decision Date2006-02-03
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II is the device name listed in this FDA 510(k) record. The listed applicant is Rossmax Internationl , Ltd.. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K053006. 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 ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II?

ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Rossmax Internationl , Ltd.. The 510(k) number is K053006.

When did ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II receive FDA 510(k) clearance?

ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II received FDA 510(k) clearance on 2006-02-03, under 510(k) number K053006.

Who is the listed applicant for ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II?

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

What is the FDA product code for ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II?

The FDA product code for ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II is DXQ.

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Other records listing Rossmax Internationl , Ltd. 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.

K020897ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400K010498WRISTWATCH BLOOD PRESSURE MONITOR A46K010190WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43

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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