FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMBRO PULSATILE MONITOR PLM 10-200
K Number: K842503
·
Decision Aug 10, 1984
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
36
Applicant Total
86
Review Days
45
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Basic Information
- Device Name
- GAMBRO PULSATILE MONITOR PLM 10-200
- K Number
- K842503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gambro, Inc.
- Date Received
- June 26, 1984
- Decision Date
- August 10, 1984
- Product Code
- DWA
- 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Gambro, Inc.
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|---|---|---|---|
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| K032431 | PRISMA M60/M100 SETS | Sep 15, 2003 | Substantially Equivalent |
| 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 |