510(k) K981069
K981069 is an FDA 510(k) premarket notification submitted by International Medical Products B.V. for the device "ULTRA-COVER PU-TRANSDUCER COVER". The FDA issued a decision of Substantially Equivalent on September 23, 1998. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. International Medical Products B.V. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1998
- Date Received
- March 24, 1998
- 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