FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
CARDIOCAP(TM) CMX-104 MONITOR
K Number: K896190
·
Decision Mar 8, 1990
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
55
Review Days
133
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Basic Information
- Device Name
- CARDIOCAP(TM) CMX-104 MONITOR
- K Number
- K896190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Datex Division Instrumentarium Corp.
- Date Received
- October 26, 1989
- Decision Date
- March 8, 1990
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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