ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350

K052727 · Rossmax International , Ltd. · DXN · Dec 16, 2005 · Cardiovascular

Device Facts

• Record ID: K052727
• Device Name: ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
• Applicant: Rossmax International , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, diastolic blood pressure and pulse rate for adult individual in a home environment.

Device Story

Rossmax S380 and K350 are non-invasive blood pressure monitors for home use. Devices measure systolic/diastolic blood pressure and pulse rate in adult patients. Operation involves cuff inflation/deflation; automated signal processing of pressure oscillations to determine blood pressure values. Output displayed on integrated screen for patient review. Intended for self-monitoring of blood pressure in home settings.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Non-invasive blood pressure monitor; oscillometric measurement principle; electronic/automated; intended for home use; cuff size 15-22cm.

Indications for Use

Indicated for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in adults in a home environment. Cuff size range 15-22cm.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the border of the circle.

DEC 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rossmax International Ltd. c/o Mr. Tzu-Wei Li Manager Industrial Technology Research Institute Bldg. 16, 321 Kuang Fu Rd. Sec. 2 Hsinchu Taiwan 30042 R.O.C.

Re: K052727

K052727
Trade Name: Rossmax S380 and K350 Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 15, 2005 Received: November 17, 2005

## Dear Mr. Li:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematics from stantially equivalent (for the indications for referenced above and nave decimined the aconvents marketed in interstate comments, or to devices that use stated in the enclosure) to legally man color of the Medical Device Amendments, or to devices that prior to May 28, 1976, the enactinent date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Pedication (PMA). You may have been reclassified in accordance with the provisition (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the general Act (Act) that do not require approval of a premainco sprovisions of the Act. The general therefore, market the device, subject to the general semannial registration, listing of devices, good
controls provisions of the Act include requirements for annual regulters controls provisions of the Act merade requirements assust misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo eliner regulations affecting your device can be may be subject to such adultional controls. Existing of the South and States of Financial of found in the Code of Feach in a and in the Federal Register.

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## Page 2 – Mr. Tzu-Wei Li

Please be advised that FDA's issuance of a substantial equivalence determination access of the At Please be advised that FDA 's Issualice of a substance of the requirements of the Act or that FDA has made a deletinination that your devices of agencies. You must comply with any Federal Statutes and regulations administered of by but not listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration and lists i all the Act s requirements, menufacturing practice requirements as set forth in the quality [abeling (21 CFR 1 art 801), good manadiation production of the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic prod Systems (QB) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisious (Sections 551-942 or the 110), device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a loggios to loggi I his letter will anow you to begin maneting your avree quivalence of your everyte your doys premarket nothication. The PDA midning of sactainled of a lovice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your device of your access note the regulation entitled, contact the Office of Compilance at (210) 276 - 3279 Part 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may " Misoraliding of reference to promation in the Act from the Division of Small
general information on your responsibilities under the Act from the Division of Small general information on your responsionates and its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its to the constitudes html Manufacturers, International and Consulter Assistance and Collectivindustry/support/index.html.

Sincerely yours,

Blumman for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K052727

## Indications for Use

510(k) Number (if known):

Device Name: Rossamx S380, K350 Blood Pressure Monitors

Indications For Use:

S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, S380, K.350 are non-invasive blood prossure menters and .5~22cm for adult individual in a home environment.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

> Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blossom

510(k) Number

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