NIVP3 (Windows Version of Nivp
FDA 510(k) K970570 · D. E. Hokanson, Inc.
510(k) numberK970570
Submission
- Device name
- NIVP3 (Windows Version of Nivp
- Applicant
- D. E. Hokanson, Inc.
Bellevue, WA, US - Received
- February 14, 1997
- Decision date
- October 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was NIVP3 (Windows Version of Nivp cleared by the FDA?
NIVP3 (Windows Version of Nivp (K970570) received a 510(k) decision of Substantially Equivalent on October 3, 1997, 231 days after the submission was received.
What is the product code of K970570?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.