OVULATION CALCULATOR/CONCEPTION CALCULATOR
FDA 510(k) clearance K954183 · decided 1996-02-29
Clearance details
- K-number
- K954183
- Device name
- OVULATION CALCULATOR/CONCEPTION CALCULATOR
- Applicant
- Hector Vides
- Decision
- Substantially Equivalent
- Date received
- 1995-09-06
- Decision date
- 1996-02-29
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- MPT
- Device class
- 2
- Regulation number
- 884.5350
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.