BASIS FLEXIBLE TIP DIGITAL THERMOMETER
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
Related Devices
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- K021048 — THERMOMETER MODELS ST8631 · Z7 International · Apr 22, 2002
- K122912 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) · Hangzhou Hua'An Medical & Health Instruments Co., · Nov 7, 2012
