FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
K Number: K920949
·
Decision May 15, 1992
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
145
Review Days
74
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Basic Information
- Device Name
- SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
- K Number
- K920949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- March 2, 1992
- Decision Date
- May 15, 1992
- Product Code
- GKZ
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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