(202 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Not Found
This redacted FDA 510(k) summary only includes the formal letter approving the device for market, the device's indications for use, and a cover sheet. It does NOT contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot provide the requested information.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 2005
Omron Healthcare, Inc. c/o Mr. Iwao Kojima Director of Technology 1200 Lakeside Drive Bannockburn, IL 60015
Re: K042505
Trade Name: OMRON DIGITAL Wrist Blood Pressure Monitor HEM-609N Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: February 7, 2005 Received: February 8, 2005
Dear Mr. Kojima:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally to regally the Medical Device American procession in the commerce proof to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may, therefore, manov of the Act include requirements for annual registration, listing of general controls provisions of the line, and prohibitions against 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 (500 abor 0) ins existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may oc subject to suell additions, Title 21, Parts 800 to 898. In addition, ITDA may be found in the Obat in the Obacerning your device in the Federal Register.
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Page 2 – Mr. Iwao Kojima
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dri i losaantes syour device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I cacial statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607); adoning (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product lauditori control provisions (sevice as described in your Section 510(k) This icitel will anow you to begin maing of substantial equivalence of your device to a legally prematication. The Pice 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 If you desire specific advice 101-704-2011) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoralianing of reference to presensibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Bzimmerma 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
K042505 510(k) Number:
OMRON Device Name: DIGITAL WRIST BLOOD PRESSURE MONITOR MODEL: HEM-609N
Indications For Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X 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)
Blammana
Page 1 of _ I
(Division Sign-Off) Division of Cardioyascular Devices 510(k) Number 042505
§ 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).