FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMBRO WATER PURIFICATION MONITOR WRD
K Number: K811678
·
Decision Jul 10, 1981
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
116
Applicant Total
86
Review Days
25
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Basic Information
- Device Name
- GAMBRO WATER PURIFICATION MONITOR WRD
- K Number
- K811678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gambro, Inc.
- Date Received
- June 15, 1981
- Decision Date
- July 10, 1981
- Product Code
- FIP
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIP | Subsystem, Water Purification | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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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 |
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