DMS 300-7

FDA 510(k) K062007 · Diagnostic Monitoring Software

Substantially Equivalent

510(k) numberK062007

Submission

Device name
DMS 300-7
Applicant
Diagnostic Monitoring Software
Stateline, NV, US
Received
July 17, 2006
Decision date
August 16, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DSH – Recorder, Magnetic Tape, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Specialty
Cardiovascular

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More from Bardy Diagnostics, Inc.

510(k)DeviceDecision
K133014DMS 300-2W Holter ECG RecorderMWJ · Special 05/19/2014SE
K062959DMS 300-2, 300-3 and 300-4MWJ · Special 10/16/2006SE
K062088Premier 11 HolterMLO · Special 08/25/2006SE
K911615Holter 24-HOUR ECG System, Model Number: DMS 300DQK · Traditional 01/08/1992SE

Questions and answers

When was DMS 300-7 cleared by the FDA?

DMS 300-7 (K062007) received a 510(k) decision of Substantially Equivalent on August 16, 2006, 30 days after the submission was received.

What is the product code of K062007?

The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.