(352 days)
Replacement battery for Site Micro Surgical Systems (Keeler Optical) 1919-P-5020 Medic Lux 1919-P-5020, 510(k) Number K832437.
This battery is shipped only to customers who request a replacement battery for a particular device or to the biomedical equipment technician therefore knows the intended use is as a replacement battery.
Rechargeable Batteries (Part Numbers Trade Name: MS401097-17, MS720, MS721, MS722, and MS722-K)
This document is a 510(k) clearance letter from the FDA for rechargeable batteries (Trade Name: MS401097-17, MS720, MS721, MS722, and MS722-K). It declares the substantial equivalence of these devices to legally marketed predicate devices.
The provided document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria for a medical device that would typically involve performance metrics like sensitivity, specificity, or reader studies.
The letter focuses on regulatory clearance based on substantial equivalence to existing devices, not on a detailed analysis of performance metrics. Therefore, I cannot generate the requested information based on the input document.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jon Gamerdinger Alexander Manufacturing Company " 3 、川 1511 South Garfield Place Mason City, Iowa 50401
Re : K962767 Rechargeable Batteries (Part Numbers Trade Name: MS401097-17, MS720, MS721, MS722, and MS722-K Regulatory Class: II Product Code: HLJ Dated: April 7, 1997 Received: April 10, 1997
Dear Mr. Gamerdinger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the abrially 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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
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Page 2 - Mr. Gamerdinger
Product Radiation Control provisions, or other Federal laws or requlations.
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
Timothy R. Ulatowski
Timo Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number: | 962767 |
|---|---|
| Device Name: | MS722-K |
Indications for Use:
Replacement battery for Site Micro Surgical Systems (Keeler Optical) 1919-P-5020 Medic Lux 1919-P-5020, 510(k) Number K832437.
This battery is shipped only to customers who request a replacement battery for a particular device or to r nis bakery to enipped only to the biomedical equipment technician therefore knows the intended use is as a replacement battery.
PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
Palacia Crucoriti
510(k) Number K962767
Prescription Use
റ്റു
OVER-THE-COUNTER USE
(optional Form 1-2-96)
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.