Clearance Summary
LATEX ULTRASONIC PROBE COVER received FDA 510(k) clearance under submission number K022156, sponsored by Pleasure Latex Products Sdn. Bhd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-09-11.
- Submission: K022156
- Applicant / Sponsor: Pleasure Latex Products Sdn. Bhd.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2003-09-11
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.