FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
K Number: K822823
·
Decision Oct 18, 1982
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
2
Review Days
27
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Basic Information
- Device Name
- HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
- K Number
- K822823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Eko Scann AB
- Date Received
- September 21, 1982
- Decision Date
- October 18, 1982
- Product Code
- LKM
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| LKM | Counter, Urine Particle | FDA class 2 | Hematology |
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Other Clearances by Eko Scann AB
| K Number | Device Name | ||
|---|---|---|---|
| K822873 | DEVETHERM | Mar 24, 1983 | Substantially Equivalent |