(249 days)
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.
Automatic Blood Pressure Recording Device
The provided document is a 510(k) clearance letter from the FDA for a blood pressure device. It does not contain acceptance criteria, detailed study information, or performance metrics in the format requested. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not specify the studies performed to demonstrate this equivalence, nor does it provide performance data.
Therefore, I cannot extract the information required to populate the table and answer the specific questions about acceptance criteria and study details. The document primarily focuses on regulatory clearance based on substantial equivalence, rather than a detailed presentation of performance study results.
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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.
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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 (301) 594-4648. advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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 __
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).