510(k) K951721
K951721 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE". The FDA issued a decision of Substantially Equivalent on July 11, 1995. The device falls under product code LYK (Angioscope), 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
- July 11, 1995
- Date Received
- April 14, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Angioscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- CV
- Submission Type