AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER

K983048 · American Electromedics Corp. · EWO · Nov 17, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K983048
• Device Name: AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
• Applicant: American Electromedics Corp.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Nov 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The device is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Device Story

The American Electromedics Quik Tymp 2 (QT2) is a combination tympanometer and audiometer featuring an integral printer. It is used by clinicians to conduct hearing evaluations and assist in diagnosing otologic disorders. The device functions by performing impedance testing (tympanometry) and audiometric testing. Results are processed and can be printed directly via the built-in printer for clinical review. The device is intended for professional use in clinical settings to aid in patient assessment.

Technological Characteristics

Combination tympanometer and audiometer; includes integral printer. Device operates as a diagnostic tool for hearing evaluation.

Indications for Use

Indicated for patients requiring hearing evaluations and diagnosis of otologic disorders.

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Predicate Devices

• Car Tympanometer With Race Audiometer
• Quik Tymp2 (K970279)
• Quik Tymp1 (K970279)

Submission Summary (Full Text)

{0}------------------------------------------------

NOV 17 1998

K983048

## 510(k) SUMMARY

- American Electromedics Corporation A. Manufacturer: 13 Columbia Drive Suite 5 Amherst, NH 03031
Ferguson Medical Submitted By: Consultant to American Electromedics Corporation

- [phone] B. Contact Information: Phone: FAX: [phone]
- Auditory Impedance Tester, and C. Classification Name: Audiometer

Tympanometer/Audiometer Common/usual Name:

American Electromedics Quik Tymp 2 Proprietary Name: (QT2) Tympanometer/Audiometer With Integral Printer

- D. Classification Number: 77ETY and 77EWO
- E. Substantial Equivalence: Car Tympanometer With Race Audiometer and Quik Tymp2, and Quik Tymp1, American Electromedics Corporation (K970279)
- Electromedics Quik F. The American Device Description: Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer.
- G. Intended Use : The device is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
- H. Technological Characteristics: The American Quik Tymp 2 (QT2) Electromedics Tympanometer/ Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows a logo and the date November 17, 1998. The logo is for the Department of Health & Human Services. The date is written in a simple, sans-serif font and is located below the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

American Electromedics Corporation c/o Ferguson Medical Frank Ferguson 2581 California Park Drive, Suite 269 Chico, CA 95928

Re:

K983048 American Electromedics Ouik Tymp 2 (OT2) Tympanometer/Audiometer with Integral Printer Dated: August 1, 1998 Received: September 1, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO 21 CFR 874.1090/Procode: 77 ETY

Dear Mr. Ferguson:

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 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 (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 531 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(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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrividsmadsmam.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (If known):

American Electromedics Quik Tymp 2 (QT2) Tympanometer/ Device Name: Audiometer With Integral Printer

Indications For Use:

The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinilla Sevens
Sir. OFF.

ision Sign-Off) Division of Rone motive, Abdominal, Bidi, and Radicles 510(k) Numuu

Prescription Use
(Per 21 CFR 801.109) \$\checkmark\$

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)