510(k) K760994
K760994 is an FDA 510(k) premarket notification submitted by Dravon Medical, Inc. for the device "MONITOR LINE W/FILTER & NEEDLE". The FDA issued a decision of Substantially Equivalent on January 6, 1977. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Dravon Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1977
- Date Received
- November 8, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type