FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYGENATOR 10
K Number: K823343
·
Decision Dec 15, 1982
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
86
Review Days
37
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Basic Information
- Device Name
- OXYGENATOR 10
- K Number
- K823343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gambro, Inc.
- Date Received
- November 8, 1982
- Decision Date
- December 15, 1982
- Product Code
- DTZ
- 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K896758 | GAMBRO BICARBONATE MONITOR BCM 10-3 | Sep 28, 1990 | Substantially Equivalent |
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| K902481 | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER | Jul 27, 1990 | Substantially Equivalent |
| K900918 | GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER | Jul 16, 1990 | Substantially Equivalent |
| K892523 | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY | May 11, 1989 | Substantially Equivalent |
| K890112 | ENGSTROM ELIZA + CO2 ANALYZER | Mar 15, 1989 | Substantially Equivalent |
| K890111 | GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER | Feb 8, 1989 | Substantially Equivalent |