FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
K Number: K983102
·
Decision Apr 12, 1999
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
17
Review Days
221
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Basic Information
- Device Name
- CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
- K Number
- K983102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cambridge Heart, Inc.
- Date Received
- September 3, 1998
- Decision Date
- April 12, 1999
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Cambridge Heart, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100362 | CAMBRIDGE HEART OEM | Apr 14, 2010 | Substantially Equivalent |
| K050225 | HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM | Apr 7, 2005 | Substantially Equivalent |
| K022152 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | Jul 16, 2002 | Substantially Equivalent |
| K022149 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | Jul 16, 2002 | Substantially Equivalent |
| K013564 | MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | Nov 21, 2001 | Substantially Equivalent |
| K013565 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | Nov 21, 2001 | Substantially Equivalent |
| K012206 | ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM | Oct 12, 2001 | Substantially Equivalent |
| K011324 | CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM | May 23, 2001 | Substantially Equivalent |
| K010758 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS | Apr 12, 2001 | Substantially Equivalent |
| K010756 | CH 2000 CARDIAC DIAGNOSTIC SYSTEM | Apr 12, 2001 | Substantially Equivalent |