FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 100 BICARBONATE CONDUCTIVITY
K Number: K821834
·
Decision Jul 2, 1982
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
60
Applicant Total
7
Review Days
10
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Basic Information
- Device Name
- MODEL 100 BICARBONATE CONDUCTIVITY
- K Number
- K821834
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Western Laboratories Corp.
- Date Received
- June 22, 1982
- Decision Date
- July 2, 1982
- Product Code
- FKQ
- 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 |
|---|---|---|---|
| FKQ | System, Dialysate Delivery, Central Multiple Patient | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Western Laboratories Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K834024 | HEPARINOMETER | Jun 11, 1984 | Substantially Equivalent |
| K830468 | MODEL 200 | Apr 12, 1983 | Substantially Equivalent |
| K821415 | MODEL 90 BC | May 27, 1982 | Substantially Equivalent |
| K821414 | MODEL 80 BC | May 27, 1982 | Substantially Equivalent |
| K801303 | MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST | Jul 28, 1980 | Substantially Equivalent |
| K780932 | MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT | Aug 31, 1978 | Substantially Equivalent |