Last synced on 13 June 2025 at 11:06 pm

Manometer, Spinal-Fluid

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
880.2500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 880.2500 Spinal fluid manometer

§ 880.2500 Spinal fluid manometer.

(a) Identification. A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid.

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

Manometer, Spinal-Fluid

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
880.2500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 880.2500 Spinal fluid manometer

§ 880.2500 Spinal fluid manometer.

(a) Identification. A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid.

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