FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇭 Switzerland
BIOSELF 2000 FERTILITY INDICATOR
K Number: K904211
·
Decision Oct 14, 1992
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
23
Applicant Total
3
Review Days
763
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Basic Information
- Device Name
- BIOSELF 2000 FERTILITY INDICATOR
- K Number
- K904211
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Bioself, Inc.
- Date Received
- September 12, 1990
- Decision Date
- October 14, 1992
- Product Code
- LHD
- Advisory Committee
- Unknown
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| LHD | Device, Fertility Diagnostic, Proceptive | FDA unclassified | Unknown |
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