FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATA MASTER PERFUSION MONITORING SYSTEM
K Number: K001388
·
Decision Jul 28, 2000
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
46
Applicant Total
5
Review Days
87
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Basic Information
- Device Name
- DATA MASTER PERFUSION MONITORING SYSTEM
- K Number
- K001388
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.4330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dideco
- Date Received
- May 2, 2000
- Decision Date
- July 28, 2000
- Product Code
- DRY
- 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 |
|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Dideco
| K Number | Device Name | ||
|---|---|---|---|
| K004001 | MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR | Oct 4, 2001 | Substantially Equivalent |
| K010478 | DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR | Sep 27, 2001 | Substantially Equivalent |
| K936220 | DIDECO VACUUM PUMP | Jan 27, 1995 | Substantially Equivalent |
| K940519 | DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM | Jan 19, 1995 | Substantially Equivalent |