Microlife Automatic Blood Pressure Monitor

Q: What is the product code of K970211?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.

FDA 510(k) K970211 · Micro Weiss Electronics

Substantially Equivalent

510(k) numberK970211

Submission

Device name: Microlife Automatic Blood Pressure Monitor
Applicant: Micro Weiss Electronics
Great Neck,, NY, US
Received: January 21, 1997
Decision date: April 30, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DPW – Flowmeter, Blood, Cardiovascular
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2100
Specialty: Cardiovascular

Other 510(k)s with product code DPW

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K260700	BlueDop Vascular ExpertDPW · Traditional	BlueDop Medical, Ltd.	07/08/2026SE
K252810	FloPatch FP120DPW · Special	Flosonics Medical	04/24/2026SE
K251904	VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional	Remington Medical, Inc.	11/20/2025SE
K251114	FloPatch FP120DPW · Traditional	Flosonics Medical	06/20/2025SE
K243852	Elfor-LDPW · Traditional	Elfi-Tech , Ltd.	04/14/2025SE
K241583	VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special	Remington Medical, Inc.	08/30/2024SE
K223843	FloPatch FP120DPW · Traditional	Flosonics Medical	05/03/2023SE
K222242	FloPatch FP120DPW · Traditional	Flosonics Medical	12/09/2022SE
K213974	GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special	Synovis Micro Companies Alliance, Inc.	04/20/2022SE
K211589	VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional	Remington Medical, Inc.	01/27/2022SE

More from Remington Medical, Inc.

510(k)	Device	Decision
K970139	Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIODPW · Traditional	04/30/1998SE
K972259	Pro Check Digital Pacifier ThermometerFLL · Traditional	07/10/1997SE

Questions and answers

When was Microlife Automatic Blood Pressure Monitor cleared by the FDA?

Microlife Automatic Blood Pressure Monitor (K970211) received a 510(k) decision of Substantially Equivalent on April 30, 1998, 464 days after the submission was received.

What is the product code of K970211?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.