FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SQA V, SPERM QUALITY ANALYZER
K Number: K021746
·
Decision Sep 20, 2002
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
27
Applicant Total
2
Review Days
115
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Basic Information
- Device Name
- SQA V, SPERM QUALITY ANALYZER
- K Number
- K021746
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Electronic Systems, LLC
- Date Received
- May 28, 2002
- Decision Date
- September 20, 2002
- Product Code
- POV
- 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 |
|---|---|---|---|
| POV | Semen Analysis Device | FDA class 2 | Hematology |
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Other Clearances by Medical Electronic Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K012352 | SQA, SPERM QUALITY ANALYZER | Sep 21, 2001 | Substantially Equivalent |