BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER

K962991 · Polymedica Industries, Inc. · FLL · Sep 12, 1996 · General Hospital

Device Facts

• Record ID: K962991
• Device Name: BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
• Applicant: Polymedica Industries, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Sep 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.

Device Story

Clinical thermometer integrated into pacifier form factor; measures oral body temperature in infants/young children. Device operates as electronic thermometer for intermittent temperature determination. Used by caregivers/parents in home or clinical settings. Provides digital temperature readout to assist in monitoring patient health status.

Clinical Evidence

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

Technological Characteristics

Electronic thermometer; pacifier form factor; conforms to ASTM E1112; meets safety standards for baby pacifiers.

Indications for Use

Indicated for oral body temperature measurement in infants and young children.

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

• WeeCare™ Pacifier Thermometer (Questech International, Inc.)
• Paci-Temp Pacifier with Digital Thermometer (Intelligent Product Limited Company)

Submission Summary (Full Text)

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K962991

510(k) Basis® Baby-Temp Pacifier Digital Thermometer PolyMedica Industries, Inc.

SEP 12 1996

# 510(k) Summary

| Proprietary Name: | Basis® Baby-Temp Pacifier Digital Thermometer |
| --- | --- |
| Common Name: | Pacifier Digital Thermometer |
| Classification: | Unknown |
| Submitter Details: | PolyMedica Industries, Inc.
581 Conference Place
Golden, CO 80401
Tel: [phone]
Fax: [phone]
Contact: Ms. Julie Chaffee |

The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.

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". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.

Basis® Baby-Temp Pacifier Digital Thermometer is substantially equivalent to Questech International, Inc. WeeCare™ Pacifier Thermometer and to Intelligent Product Limited Company Paci-Temp Pacifier with Digital Thermometer.

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