(30 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Not Found
The provided text is a 510(k) clearance letter for the Omron Automatic Blood Pressure Monitor, Model HEM-711AC. This type of document declares a device to be "substantially equivalent" to a predicate device, meaning it's as safe and effective as a device already legally marketed. It does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) clearance process generally involves demonstrating substantial equivalence through various means, which can include performance data, but the specific details of such studies and acceptance criteria are typically found in the submission itself, not the clearance letter.
Therefore, I cannot provide the requested information from the given text. The document only states that the device is cleared for marketing based on substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2005
Omron Healthcare, Inc. c/o Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories Inc. 333 Pfingsten Road Northbrook, IL 60062
Re: K052154
Trade Name: Omron Automatic Blood Pressure Monitor, Model HEM-711AC Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 24, 2005 Received: August 25, 2005
Dear Ms. Ankova:
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 - Ms. Silvia Ankova
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active in the start of the samplies with other requirements of the Ac Please be advised that FDA's issuance of a substantial complies with other requirements of the Act
that FDA has made a determination that your device aderal agencies. You mu that FDA has made a determination inalyou divisions aderal agencies. You must
or any Federal statutes and regulations administered by other Federal on and listi or any Federal statutes and regulations administred to: recisitation and listing
comply with all the Act's requirements, including, but not limited to: requirements a comply with all the Act's requirements, including out not many of seguirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements (21 CFR Part 807); labeling (21 CFR Part 801); good manataly; and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applica forth in the quality systems (QS) regulation (2) -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 31 casescri)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalevice and premarket notification. The FDA finding of substantial equivalite of 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
r (1) (1) (1) (1) (1) (1) (1) (1) (11) (11) (11) (1) (1) (1) (1) (1) (1) If you desire specific advice for your device on our hoomig regulation entitled,
contact the Office of Compliance at (240) 276-0295. Also, please note the regulation in contact the Office of Compliance at (240) 270-02-27 Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to prematical ionnitation " (2) Cr Cr Architer of Small
other general information on your responsibilities under the Act from the (800) 638-204 other general information on your responsibilities under (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (800) on Manufacturers, International and Consumer Assistance at 10 for Ire Same (4)
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimimova 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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INDICATION FOR USE STATEMENT
Applicant:
OMRON HEALTHCARE, INC.
510(k) Number:
K
Device Name:
Indication for Use:
OMRON Automatic Blood Pressure Monitor, Model: HEM-711ACN
(OMRON Internal Model Name: HEM-7011-Z)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.
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
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)
Blumimor
Islon Slan-Of rdiovascular D
Page 1 of
§ 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).