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TV Monitor Model P12/17 SCREEN (CRT)
The provided document is a 510(k) clearance letter from the FDA for a TV Monitor Model P12/17. This letter is a regulatory document and does not contain information about acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document.
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Image /page/0/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HU" is visible, curving around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 1997
Jim Furse Re: K972136 Vice President TV Monitor Model P12/17 Manufacturing & Engineering Dated: June 5, 1997 Perkins Manufacturing, Co. Received: June 6, 1997 1510 N. Washington Ave. ... ....... Regulatory class: II Dallas, Texas 75204 21 CFR 892.1600/Procode: 90 IZI
Dear Mr. Furse:
We have reviewed your Secuon 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 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). 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 and prohibitions gainst 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
This letter will allow you to begin marketing your device as described in your 510(x) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): __ 972136 Device Name:__________________________________________________________________________________________________________________________________________________________________
11
Indications For Use:
1,0 11 . Diffe STONDARI) 12 OR / 7 SCREFIN (CRT)
Image /page/1/Picture/4 description: The image contains a signature and some text. The name "JAMES J. FURRE" is written in block letters. Below the name, the text "VP MFG & ENG." is written, indicating a job title.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
EEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972136
Prescription Use_ (Per 21 CFR 801 109)
ರಿನ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.