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Device, Skin Potential Measurement

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
882.1560
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1560 Skin potential measurement device

§ 882.1560 Skin potential measurement device.

(a) Identification. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]

Device, Skin Potential Measurement

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
882.1560
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1560 Skin potential measurement device

§ 882.1560 Skin potential measurement device.

(a) Identification. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]