HORTMANN AMDIS-OAE OAE ANALYZER

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a profile view of a person's head and shoulders. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 7 1998 Bradford. Melancon c/o Danplex-Hortmann, Inc. P.O. Box 119 Dripping Spring, TX 78620 Re: K980505 Hortmann AmDIS-OAE Otoacoustic Emissions Analyzer Dated: February 4, 1998 Received: February 9, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO Dear Mr. Melancon: 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 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 practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either 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 (OS) 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 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(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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/cdrb/dsmaldsmamain.html". Sincerely yours, Kilian Yi 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 {1}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number (if known): K980505 Device Name: Hortmann AmDIS-OAE Otoacoustic Emissions Analyzer .2011 11:14 | 1 Indications For Use: Use of the AmDiS otoacoustic Emissions Test Instrument is indicated in any case which requires objective assessment of the inner ear function, e.g., during hearing screening in infants, or for the documentation of ocupational hearing loss. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)---- Thiriel C. Sygmm (Division Sign-Off) Division of Reproductive. Abdominal, ENT, and Radioingreal Ca 510(k) Number V Prescription Use _ (Per 21 CFR 801.109)