510(k) K843247
K843247 is an FDA 510(k) premarket notification submitted by Koi, Inc. for the device "KOI PACHYMETER". The FDA issued a decision of Substantially Equivalent on April 30, 1986. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Koi, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 1986
- Date Received
- August 20, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type