MEDFUSION 2001 & 2010, MODEL N7215IWC

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract eagle or bird with three curved lines representing its wings or feathers. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 2 2001 Mr. Don Pelletier President National Custom Enterprises, Incorporated 1133 East Cliff Road Burnsville, Minnesota 55337 Re: K012259 Trade/Device Name: Medfusion 2001 & 2010, Model N7215IWC Regulation Number: 880.5725 Regulation Name: Pump, Infusion-Accessory; Replacement Battery Pack FRN Regulatory Class: II Product Code: MRZ and MOQ Dated: July 18, 2001 Received: July 18, 2001 Dear Mr. Pelletier: 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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {1}------------------------------------------------ ## Page 2 - Mr. Pelletier You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with and and manufacturing (21 CFR Part 801); good manufacturing practice and instills (21 CF 21 regulation (QS) regulation (21 CFR Part 820); and if requirence as ecoronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050. This letter will allow you to begin marketing your device as described in your 510(k) Trans reter wification. The FDA finding of substantial equivalence of your device to a promative nouried aredicate 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/cdrh/dsma/dsmamain.html. Sincerely yours, L. Chilton Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Applicant: National Custom Enterprises, Inc. (800) 328-3773 510(k) Number: 长の12スタタ N7215IWC Device Name: Indications For Use: Replacement battery pack for_ MEDFUSION, INC. 2001 & 2010 INFUSION PUMP This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 1 (Per 21 CFR 801.109) Over-The-Counter Use 나 Patrua Lucente OR (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _