Biosensor Bidop Vascular Test System
FDA 510(k) K943338 · Biosensor Corp.
510(k) numberK943338
Submission
- Device name
- Biosensor Bidop Vascular Test System
- Applicant
- Biosensor Corp.
Minneapolis, MN, US - Received
- July 12, 1994
- Decision date
- April 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K974546 | Biosensor Holter Monitor SystemDQK · Traditional | 03/04/1998SE |
| K974192 | 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 |
| 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 Bidop Vascular Test System cleared by the FDA?
Biosensor Bidop Vascular Test System (K943338) received a 510(k) decision of Substantially Equivalent on April 12, 1996, 640 days after the submission was received.
What is the product code of K943338?
The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.