510(k) K954183
K954183 is an FDA 510(k) premarket notification submitted by Hector Vides for the device "OVULATION CALCULATOR/CONCEPTION CALCULATOR". The FDA issued a decision of Substantially Equivalent on February 29, 1996. The device falls under product code MPT (Contraception Calculator), a Class II device regulated under 21 CFR 884.5350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 29, 1996
- Date Received
- September 6, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Contraception Calculator
- Device Class
- Class II
- Regulation Number
- 884.5350
- Review Panel
- OB
- Submission Type