FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOSWISS CM-8
K Number: K910109
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
3
Review Days
256
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Basic Information
- Device Name
- CARDIOSWISS CM-8
- K Number
- K910109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Care Systems, Inc.
- Date Received
- January 10, 1991
- Decision Date
- September 23, 1991
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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