510(k) K960421
K960421 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "SINUSCAN 102/SINUSPRINT". The FDA issued a decision of Substantially Equivalent on April 16, 1997. The device falls under product code LWI (Ultrasound, Sinus), a Class II device regulated under 21 CFR 892.1560. Ferguson Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1997
- Date Received
- January 29, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound, Sinus
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- EN
- Submission Type