Who is the manufacturer of STRYKER PAINPUMP PCA?

Stryker Instruments submitted the Traditional clearance for STRYKER PAINPUMP PCA (K003543).

What is the FDA product code for STRYKER PAINPUMP PCA?

FRN. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for STRYKER PAINPUMP PCA?

510(k) clearance (submission type: Traditional).

STRYKER PAINPUMP PCA

K003543 · Stryker Instruments · FRN · Jun 5, 2001 · General Hospital

Device Facts

Record ID	K003543
Device Name	STRYKER PAINPUMP PCA
Applicant	Stryker Instruments
Product Code	FRN · General Hospital
Decision Date	Jun 5, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.