510(k) K925918
K925918 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "PRESSURE TURING AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Applied Medical Resources has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1993
- Date Received
- November 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type