Biosensor Holter Monitor System
FDA 510(k) K974192 · Biosensor Corp.
510(k) numberK974192
Submission
- Device name
- Biosensor Holter Monitor System
- Applicant
- Biosensor Corp.
Maple Grove, MN, US - Received
- November 7, 1997
- Decision date
- March 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990956 | Biosensor Holter Monitor System Software, Model 1005DQK · Traditional | 06/14/1999SE |
| K974546 | Biosensor Holter Monitor SystemDQK · Traditional | 03/04/1998SE |
| K950944 | Ambulatory (Holter) Recording SystemDQK · Traditional | 06/18/1996SE |
| K960449 | PC ECG 1200 ECG and Stress Electrocardiography Testing System(Version 2.90)DPS · Traditional | 05/30/1996SE |
| K943338 | Biosensor Bidop Vascular Test SystemJAF · Traditional | 04/12/1996SE |
| K950723 | Ambulatory (Holter) Recording SystemDQK · Traditional | 02/09/1996SE |
| K922027 | Ambulatory (Holter) Recording, ModificationDSI · Traditional | 02/17/1993SE |
| K895266 | Ambulatory (Holter) Recording System - ModifiedDSI · Traditional | 01/26/1990SE |
| K831676 | Biosensor Asc SystemDSI · Traditional | 12/01/1983SE |
Questions and answers
When was Biosensor Holter Monitor System cleared by the FDA?
Biosensor Holter Monitor System (K974192) received a 510(k) decision of Substantially Equivalent on March 4, 1998, 117 days after the submission was received.
What is the product code of K974192?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.