FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAT-SAT
K Number: K874839
·
Decision May 13, 1988
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
46
Applicant Total
75
Review Days
171
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Basic Information
- Device Name
- STAT-SAT
- K Number
- K874839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gish Biomedical, Inc.
- Date Received
- November 24, 1987
- Decision Date
- May 13, 1988
- 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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|---|---|---|---|
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| K080708 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATING | Feb 2, 2009 | Substantially Equivalent |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Jan 26, 2009 | Substantially Equivalent |
| K081881 | GISH TUBING AND CONNECTORS WITH HA COATING | Jan 23, 2009 | Substantially Equivalent |