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Talking Digital Thermometer
The provided document is a 510(k) summary for a Talking Digital Thermometer, dating back to 1996. It describes the device, its classification, and predicate devices.
However, the document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement. These are typically found in the clinical testing or performance validation sections of a 510(k) submission, which are not present in this summary.
Therefore, I cannot fulfill your request for the specific information you've outlined, as it is not provided in the input text. The document is a high-level summary that serves as an introduction to the device for regulatory purposes.
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510(k) SUMMARY FOR ULTMOST INDUSTRIAL CORP.'s TALKING DIGITAL THERMOMETER
AUG 20 199
Submitter's Name, Address, Telephone Number, And Contact Person
Ultmost Industrial Corp. - 4F, No. 52, Ming Chuang Road Hsintien, Tapei Taiwan, R.O.C.
| Contact: | Howard M. Holstein orHogan & Hartson, L.L.P. | Stephen FangUltmost Industrial Corp. |
|---|---|---|
| Phone: | (202) 637-5813 | 011 886 2 917 99 01 |
| Facsimile: | (202) 637-5910 | 011 886 2 917 76 03 |
Date Prepared
May 15, 1996
Name of the Device
Talking Digital Thermometer
Common or Usual Name
Digital Thermometer with Verbal Announcement
Classification Name
Clinical Electronic Thermometer (21 C.F.R. § 880.2910)
Product Code
FLL
Predicate Devices
§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.