510(k) K041395
K041395 is an FDA 510(k) premarket notification submitted by Pentax Precision Instrument Corp. for the device "EG-3630UR". The FDA issued a decision of Substantially Equivalent on June 9, 2004. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Pentax Precision Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2004
- Date Received
- May 26, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type