FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
K Number: K955152
·
Decision Feb 22, 1996
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
16
Applicant Total
13
Review Days
101
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Basic Information
- Device Name
- STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
- K Number
- K955152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stoeckert Instrumente
- Date Received
- November 13, 1995
- Decision Date
- February 22, 1996
- Product Code
- DTW
- 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 |
|---|---|---|---|
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Stoeckert Instrumente
| K Number | Device Name | ||
|---|---|---|---|
| K002273 | STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE | Jan 29, 2001 | Substantially Equivalent |
| K001961 | STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE | Jan 25, 2001 | Substantially Equivalent |
| K002118 | STOCKERT COMPACT SYSTEM VERSION 2.0 | Aug 9, 2000 | Substantially Equivalent |
| K992635 | INTERFACE MODULE IDDD | Dec 20, 1999 | Substantially Equivalent |
| 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 |
| K955038 | STOCKERT S3 DOUBLE HEAD PUMP MODULE | Feb 21, 1996 | Substantially Equivalent |