CLINICAL ELECTRONIC THERMOMETER

K982140 · Valeo Corp. · FLL · Dec 8, 1998 · General Hospital

Device Facts

• Record ID: K982140
• Device Name: CLINICAL ELECTRONIC THERMOMETER
• Applicant: Valeo Corp.
• Product Code: FLL · General Hospital
• Decision Date: Dec 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

Device Story

Clinical electronic thermometer; measures body temperature via sensor/transducer; signal amplification and conditioning; digital LCD output. Used in clinical settings for oral, axillary, or rectal measurements. Provides temperature data to healthcare providers for clinical assessment of patient health status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic thermometer; sensor/transducer input; signal amplification and conditioning circuitry; digital LCD display; reusable form factor.

Indications for Use

Indicated for patients requiring oral, axillary, or rectal body temperature measurement. Reusable device for clinical use.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 8 1998

Valeo Corporation C/O Mr. Phil Zulueta Z7 International 26792 Via Alcala Mission Viejo, California 92691-3432

K982140 Re : Clinical Electronic Thermometers Trade Name: Requlatory Class: II Product Code: ELL September 21, Dated: 1998 September 28, 1998 Received:

Dear Mr. Zulueta:

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 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). 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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

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Paqe 2 - Mr. Zulueta

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2 Statement of Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name:_ Clinical Electronic Thermometer

Indications for Use:

The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Palazzo Cucorete

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K982140

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Z7 International

"Serving the Electronics Industry"