SIBELMED AC50D

K973377 · Trutone · EWO · Mar 10, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K973377
• Device Name: SIBELMED AC50D
• Applicant: Trutone
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

This device is an audiometer, Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an cletroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.

Device Story

The Audiometer AC-50 is an electroacoustic device used by hearing health professionals in clinical settings. It functions by generating controlled levels of test tones and signals to evaluate a patient's hearing sensitivity. The device assists clinicians in diagnosing potential otologic disorders. The output is used by the healthcare provider to assess hearing thresholds and inform clinical decision-making regarding auditory health and potential interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electroacoustic device designed to produce controlled test tones and signals for hearing evaluation. Class II device under 21 CFR 874.1050.

Indications for Use

Indicated for use by hearing health professionals to conduct diagnostic hearing evaluations and assist in the diagnosis of otologic disorders in patients requiring hearing assessment.

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.

Submission Summary (Full Text)

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Ziad Shwiyat Trutone Ltd. Partnership 3113 S. 115th E. Ave. Tulsa, OK 74146

Re:

K973377

Audiometer AC-50D Dated: December 8, 1997 Received: December 17, 1997 Regulatory class: 11 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Shwiyat:

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 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 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 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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Killian Yin, Ph.D.

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

Enclosure

Image /page/0/Picture/16 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

Pago 1 of

510(k) Number (if known): 15973377

Device Name: Audiometer AC-50

Indications For Use:

This device is an audiometer, Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an cletroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.

(PLB/ SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBOBO)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973377 |

Prescription Use (Per 21 CI R 801 109)

OR

Over-The-Counter Use

(Optional Formal 1-2-90)