510(k) K022156
K022156 is an FDA 510(k) premarket notification submitted by Pleasure Latex Products Sdn. Bhd. for the device "LATEX ULTRASONIC PROBE COVER". The FDA issued a decision of Substantially Equivalent on September 11, 2003. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Pleasure Latex Products Sdn. Bhd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2003
- Date Received
- July 2, 2002
- Clearance Type
- Abbreviated
- 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