Question 1

Who is the manufacturer of ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS?

Accepted Answer

Rossmax International , Ltd. submitted the Abbreviated clearance for ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS (K011539).

Question 2

What is the FDA product code for ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS?

Accepted Answer

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

Question 3

When was ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS cleared by the FDA?

Accepted Answer

Jul 20, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS?

Accepted Answer

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

Record ID	K011539
Device Name	ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
Applicant	Rossmax International , Ltd.
Product Code	DXN · Cardiovascular
Decision Date	Jul 20, 2001
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 870.1130
Device Class	Class 2

ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS

Device Facts

Regulatory Classification

Identification