Chase Cardiac Analysis System
FDA 510(k) K032531 · Chase Medical, Inc.
510(k) numberK032531
Submission
- Device name
- Chase Cardiac Analysis System
- Applicant
- Chase Medical, Inc.
Richardson, TX, US - Received
- August 15, 2003
- Decision date
- February 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K072473 | Chase MR SystemLNH · Traditional | 12/10/2007SE |
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| K022093 | Chase Cardiovascular Patch KitDXZ · Traditional | 09/20/2002SE |
| K021129 | Chare Cariovascular PatchDXZ · Traditional | 06/03/2002SE |
| K020233 | Chase Cardiovascular Patch KitDXZ · Traditional | 03/14/2002SE |
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Questions and answers
When was Chase Cardiac Analysis System cleared by the FDA?
Chase Cardiac Analysis System (K032531) received a 510(k) decision of Substantially Equivalent on February 2, 2004, 171 days after the submission was received.
What is the product code of K032531?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.