Last synced on 2 December 2022 at 11:04 pm

Conditioner, Signal, Physiological

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1845
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1845 Physiological signal conditioner

§ 882.1845 Physiological signal conditioner.

(a) Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.

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

Conditioner, Signal, Physiological

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1845
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1845 Physiological signal conditioner

§ 882.1845 Physiological signal conditioner.

(a) Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.

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