Dynemo 3000

FDA 510(k) K972798 · Sometec, Inc.

Substantially Equivalent

510(k) numberK972798

Submission

Device name
Dynemo 3000
Applicant
Sometec, Inc.
Stoneham, MA, US
Received
July 28, 1997
Decision date
February 24, 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

510(k)DeviceApplicantDecision
K260700BlueDop Vascular ExpertDPW · Traditional BlueDop Medical, Ltd.07/08/2026SE
K252810FloPatch FP120DPW · Special Flosonics Medical04/24/2026SE
K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional Remington Medical, Inc.11/20/2025SE
K251114FloPatch FP120DPW · Traditional Flosonics Medical06/20/2025SE
K243852Elfor-LDPW · Traditional Elfi-Tech , Ltd.04/14/2025SE
K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special Remington Medical, Inc.08/30/2024SE
K223843FloPatch FP120DPW · Traditional Flosonics Medical05/03/2023SE
K222242FloPatch FP120DPW · Traditional Flosonics Medical12/09/2022SE
K213974GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special Synovis Micro Companies Alliance, Inc.04/20/2022SE
K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional Remington Medical, Inc.01/27/2022SE

Questions and answers

When was Dynemo 3000 cleared by the FDA?

Dynemo 3000 (K972798) received a 510(k) decision of Substantially Equivalent on February 24, 1998, 211 days after the submission was received.

What is the product code of K972798?

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