FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
K Number: K902493
·
Decision Jul 6, 1990
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
3
Applicant Total
55
Review Days
31
Basic Information
- Device Name
- CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
- K Number
- K902493
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2620
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- DATEX DIVISION INSTRUMENTARIUM CORP.
- Date Received
- June 5, 1990
- Decision Date
- July 6, 1990
- Product Code
- DRI
- 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 |
|---|---|---|---|
| DRI | Monitor, Line Isolation | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRI), ordered by most recent decision date.
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FDA 510(k)
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