FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUALTHERM(R) CARDIAC OUTPUT COMPUTER
K Number: K925285
·
Decision Jul 21, 1993
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
403
Applicant Total
19
Review Days
274
Basic Information
- Device Name
- DUALTHERM(R) CARDIAC OUTPUT COMPUTER
- K Number
- K925285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B. BRAUN OF AMERICA, INC.
- Date Received
- October 20, 1992
- Decision Date
- July 21, 1993
- 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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