Last synced on 27 January 2023 at 11:04 pm

Pump, Breast, Powered

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5160
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.5160 Powered breast pump

§ 884.5160 Powered breast pump.

(a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.

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

Pump, Breast, Powered

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5160
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.5160 Powered breast pump

§ 884.5160 Powered breast pump.

(a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.

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