(25 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate by using the oscillornetric method. All values can be read out in one LCD panel. The intended use of this over-the-counter-device is for over the age of 18.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and details based on the input document. The document primarily focuses on the regulatory clearance process and states that the device is substantially equivalent to legally marketed predicate devices, meaning it doesn't necessitate new clinical study data for FDA clearance in this instance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2006
I Icalth & Life Co., Ltd. Regulation Department c/o Alex Kou Quality Representative 9F., NO. 186. Jian Yi Road Chung Ho City, Taipei County TAIWAN 23553
Re: K060835
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor. Model H1.888SF Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 17. 2006 Received: March 27, 2006
Dear Mr. Kou:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Alex Kou
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.lda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimman 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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Indications for Use
5 10(k) Number (if known): K060835
Device Name: H&L Full Automatic (NIBP) Blood Pressure Montor
Indications for Use:
Measures automatically human's Systolic, Diastolic blood pressure and heart rate by using the oscillornetric method. All values can be read out in one LCD panel. The intended use of this over-the-counter-device is for over the age of 18.
Prescription List ____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use ... } AND/OR (Part 21 CFR 801 Subpart D) (2) CFR SD, Subpartu i
(PLÈASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PACE OF NEEDEDI
Companya. 1 CDRH. Offic, of Deace Budustion (1) 08
4
Bhemmma
(Division Sign-Off)
Cardiovascular Devices
Division of Cardiovascular Devices
510(k) Number K060835
§ 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).