(90 days)
The Oscillornate 9001 Monitor non-invasively measures the blood pressure of adult , and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic, mean arterial pressure and pulse rate.
Oscillomate 9001 Non-invasive Blood Pressure Monitor
This document is a 510(k) clearance letter from the FDA for the Oscillomate EMS NIBP Monitor Model 9001. It does not contain information on acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on the regulatory clearance of the device due to its substantial equivalence to a legally marketed predicate device.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized representation of three human profiles facing right, arranged in a stacked formation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the seal's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1998
Mr. Ron Jeffrey QA Manager CAS Medical Systems, Inc. Technology Applied To Medicine 21 Business Park Drive Branford, CT 06405
Re : K982135 Oscillomate EMS NIBP Monitor Model 9001 Requlatory Class: II Product Code: DXN Dated: June 16, 1998 Received: June 17, 1998
Dear Mr. Jeffrey:
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 aqainst 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 regulation (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 2 - Mr. Ron Jeffrey
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and 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"(21 CFR 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.gov/cdrh/dsma/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
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Page of of
510(k) Number (if known):
Device Name: Qscillomate 9001 Non-invasive Blood Pressure Monitor
STATEMENT OF INDICATIONS FOR USE
The Oscillornate 9001 Monitor non-invasively measures the blood pressure of adult , and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic, mean arterial pressure and pulse rate.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dee Campese li
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K982135
510(k) Number __
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).