510(k) K960648
K960648 is an FDA 510(k) premarket notification submitted by Femtek, Inc. for the device "PHEM-CHEK". The FDA issued a decision of Substantially Equivalent on May 13, 1996. The device falls under product code LNW (Paper, Obstetric Ph), a Class I device regulated under 21 CFR 862.1550. Femtek, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1996
- Date Received
- February 14, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Paper, Obstetric Ph
- Device Class
- Class I
- Regulation Number
- 862.1550
- Review Panel
- OB
- Submission Type