FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTERFACE MODULE IDDD
K Number: K992635
·
Decision Dec 20, 1999
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
41
Applicant Total
13
Review Days
136
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Basic Information
- Device Name
- INTERFACE MODULE IDDD
- K Number
- K992635
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 870.4200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stoeckert Instrumente
- Date Received
- August 6, 1999
- Decision Date
- December 20, 1999
- Product Code
- KRI
- 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 |
|---|---|---|---|
| KRI | Accessory Equipment, Cardiopulmonary Bypass | FDA class 1 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K990512 | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | Nov 23, 1999 | Substantially Equivalent |
| K982014 | STOCKERT COMPACT SYSTEM | Sep 4, 1998 | Substantially Equivalent |
| K972321 | S3 MAST PUMP | Feb 27, 1998 | Substantially Equivalent |
| K971520 | S3 CYCLIC RPM CONTROL | Sep 10, 1997 | Substantially Equivalent |
| K962320 | S3 CARDIOPLEGIA CONTROL | Jan 10, 1997 | Substantially Equivalent |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | Feb 22, 1996 | Substantially Equivalent |
| K955038 | STOCKERT S3 DOUBLE HEAD PUMP MODULE | Feb 21, 1996 | Substantially Equivalent |