TES-20

K992425 · Tes Electrical Electronic Corp. · MWJ · Oct 19, 1999 · Cardiovascular

Device Facts

• Record ID: K992425
• Device Name: TES-20
• Applicant: Tes Electrical Electronic Corp.
• Product Code: MWJ · Cardiovascular
• Decision Date: Oct 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The TES-20 is intended to be used in the recording of ECGs in an ambulatory mode for the diagnosis of various cardiac disorders. These disorders principally include cardiac arrhythmia.

Device Story

TES-20 Holter ECG Recorder; ambulatory device for continuous ECG signal acquisition. Records cardiac electrical activity over extended periods to assist clinicians in diagnosing cardiac arrhythmias. Used in clinical settings or patient homes under physician prescription. Device captures raw ECG data; stored for subsequent analysis by healthcare professionals. Output facilitates identification of transient cardiac events; supports clinical decision-making regarding arrhythmia management and patient treatment plans.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Ambulatory Holter ECG recorder; portable form factor; electronic signal acquisition. Complies with 21 CFR Part 820 Quality System Regulation.

Indications for Use

Indicated for patients requiring ambulatory ECG monitoring for the diagnosis of cardiac disorders, specifically cardiac arrhythmias.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 9 1999

Mr. Mike Z. Chen TES Electrical Electronic Corporation 57 Jen Ai Road, Sec. 2 Taipei, Taiwan 300, ROC.

K992425 Re: TES-20 Requlatory Class: II (two) Product Code: MWJ Dated: July 20, 1999 Received: July 21, 1999

Dear Mr. Chen:

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 leqally 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). 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 aqainst 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 requlations 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 (QS) for Medical Devices: General requlation (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.

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Page 2 - Mr. Mike Z. Chen

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Wolf Sapirstein, M.D.

Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K992425

Device Name: Tes Electrical Electronic Corp. TES-20 Holter ECG Recorder

Indications For Use:

The TES-20 is intended to be used in the recording of ECGs in an ambulatory mode for the diagnosis of various cardiac disorders. These disorders principally include cardiac arrhythmia.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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(Optional Format 1-2-96)

Dallas Tull

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number