510(k) K023701
K023701 is an FDA 510(k) premarket notification submitted by Living Data Technologies Corporation for the device "ANGIONEW-IV". The FDA issued a decision of Substantially Equivalent on January 30, 2003. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Living Data Technologies Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2003
- Date Received
- November 4, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Counter-Pulsating, External
- Device Class
- Class II
- Regulation Number
- 870.5225
- Review Panel
- CV
- Submission Type