510(k) K970419
K970419 is an FDA 510(k) premarket notification submitted by Daxor Corporation for the device "DAXOR MAX100 SYRINGE (MAX100)". The FDA issued a decision of Substantially Equivalent on December 22, 1997. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Daxor Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1997
- Date Received
- February 4, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type