UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE

K993316 · Ueda Avancer Corp. · DXN · Jun 9, 2000 · Cardiovascular

Device Facts

• Record ID: K993316
• Device Name: UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
• Applicant: Ueda Avancer Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 9, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Ueda Udex Super BP-2000 Automatic Blood Pressure Recording Device is designed to provide signals from which systolic and diastolic pressures can be derived based on the ausculatory blood pressure measuring method proposed by Korotkoff. The device also measures pulse rate. This device is for use by adult population ( 18 years and older.) This is a non-invasive electronic sphygmomanometer.

Device Story

Udex Super BP-2000 is an electronic sphygmomanometer; utilizes auscultatory method based on Korotkoff sounds to derive systolic/diastolic blood pressure; measures pulse rate; intended for adult use; non-invasive; provides automated recording of vital signs; assists clinicians or patients in monitoring cardiovascular status.

Technological Characteristics

Non-invasive electronic sphygmomanometer; utilizes auscultatory Korotkoff method for pressure derivation; measures pulse rate; intended for adult population.

Indications for Use

Indicated for adult population (18+ years) for non-invasive measurement of systolic/diastolic blood pressure and pulse rate using the auscultatory Korotkoff method.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

# JUN - 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Yolanda Smith Requlatory Affairs Smith Associates P.O. Box 4341 Crofton, MD 21114

Re: K993316 Trade Name: UEDA UDEX Super BP-2000 Automatic Blood Pressure Requlatory Class: II (two) Product Code: DXN March 13, 2000 Dated: Received: March 14, 2000

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, . FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{1}------------------------------------------------

Page - Ms. Yolanda Smith

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and [phone]. advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Brian E. Aumeym

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

### Page 1 of 1

#### K9933316 510(k) Number (if known):

Device Name: Udex Super BP-2000

### Indications for Use:

The Ueda Udex Super BP-2000 Automatic Blood Pressure Recording Device is designed to provide signals from which systolic and diastolic pressures can be derived based on the ausculatory blood pressure measuring method proposed by Korotkoff. The device also measures pulse rate.

This device is for use by adult population ( 18 years and older.)

This is a non-invasive electronic sphygmomanometer.

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K993316

## (PLEASE DO NOT WRITE BELOW THIA LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription Use_

**Over the Counter Use**

Use ***_***_