Last synced on 23 September 2022 at 11:05 pm

Device, Temperature Measurement, Direct Contact, Powered

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1570
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1570 Powered direct-contact temperature measurement device

§ 882.1570 Powered direct-contact temperature measurement device.

(a) Identification. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.

(b) Classification. Class II (performance standards).

Device, Temperature Measurement, Direct Contact, Powered

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1570
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1570 Powered direct-contact temperature measurement device

§ 882.1570 Powered direct-contact temperature measurement device.

(a) Identification. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.

(b) Classification. Class II (performance standards).