BASIS FLEXIBLE TIP DIGITAL THERMOMETER

K971045 · Polymedica Industries, Inc. · FLL · May 2, 1997 · General Hospital

Device Facts

• Record ID: K971045
• Device Name: BASIS FLEXIBLE TIP DIGITAL THERMOMETER
• Applicant: Polymedica Industries, Inc.
• Product Code: FLL · General Hospital
• Decision Date: May 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

Device Story

Digital thermometer with flexible tip; measures human body temperature via oral, rectal, or axillary sites. Device utilizes electronic sensing technology to determine temperature; provides digital readout for clinician or patient use. Intended for intermittent temperature monitoring; aids in clinical assessment of patient health status.

Clinical Evidence

Bench testing only; device conforms to ASTM E1112 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature.

Technological Characteristics

Electronic thermometer; flexible tip design; conforms to ASTM E1112 standards. Digital display output.

Indications for Use

Indicated for oral, rectal, and axillary body temperature measurement in humans of all ages.

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.

Predicate Devices

• Basis® Digital Thermometer (PolyMedica Industries, Inc.)
• Becton Dickinson Flexible™ Digital Thermometer

Submission Summary (Full Text)

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K971045

510(k) Basis® Flexible Tip Digital Thermometer
PolyMedica Industries, Inc.

MAY - 2 1997

510(k) Summary

Proprietary Name: Basis® Flexible Tip Digital Thermometer

Common Name: Digital Thermometer with Flexible Tip

Classification: Class II

Submitter Details: PolyMedica Industries, Inc.
581 Conference Place
Golden, CO 80401
Tel: [phone]
Fax: [phone]
Contact: Ms. Susan Collins

The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.

In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature".

Basis® Flexible Tip Digital Thermometer is substantially equivalent to PolyMedica Industries, Inc's Basis® Digital Thermometer and the Becton Dickinson Flexible™ Digital Thermometer.

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