Clinical Electronic Thermometer
A clinical electronic thermometer is a General Hospital device used to intermittently measure a patient's body temperature via a transducer coupled with electronic signal amplification, conditioning, and display; this product code represents the Class II exempt category that does not require premarket notification (510(k)) provided it does not exceed the general and specific limitations of exemption. It is classified as FDA Class II under regulation 880.2910 in the General Hospital specialty, with product code SDV, and was exempted under procedures established by section 510(m) of the FD&C Act as described in 90 FR 25889. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SDV
- Device Class
- FDA class 2
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf
FEI Numbers
This FDA classification entry is associated with 94 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 94 registration numbers. Click on an entry to view related FDA registrations.