Angionew-Iv
FDA 510(k) K023701 · Living Data Technologies Corporation
510(k) numberK023701
Submission
- Device name
- Angionew-Iv
- Applicant
- Living Data Technologies Corporation
Great Neck, NY, US - Received
- November 4, 2002
- Decision date
- January 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRN – Device, Counter-Pulsating, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5225
- Specialty
- Cardiovascular
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More from Ecp Health, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033657 | Mobile External Counter Pulsation System Angionew-VDRN · Special | 12/19/2003SE |
Questions and answers
When was Angionew-Iv cleared by the FDA?
Angionew-Iv (K023701) received a 510(k) decision of Substantially Equivalent on January 30, 2003, 87 days after the submission was received.
What is the product code of K023701?
The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.