Non Invasive Vascular Program
FDA 510(k) K932852 · D. E. Hokanson, Inc.
510(k) numberK932852
Submission
- Device name
- Non Invasive Vascular Program
- Applicant
- D. E. Hokanson, Inc.
Bellevue, WA, US - Received
- June 10, 1993
- Decision date
- February 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOB – Hexane Extraction, Fluorescence, Vitamin E
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1815
- Specialty
- Clinical Chemistry
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|---|---|---|
| K041689 | Polyurethane Blood Pressure CuffsDXQ · Special | 08/06/2004SE |
| K033156 | OB1 Obstetrical DopplerKNG · Traditional | 12/09/2003SE |
| K023707 | A16 Blood Flow Measurement SystemJOM · Special | 02/12/2003SE |
| K982707 | EC6 PlethysmographJOM · Special | 08/26/1998SE |
| K973426 | Ans 2000 ECG Monitor and Respiration PacerDPS · Traditional | 08/12/1998SE |
| K970570 | NIVP3 (Windows Version of NivpDQK · Traditional | 10/03/1997SE |
| K932812 | Ec 5R PlethysmographJEH · Traditional | 01/13/1994SE |
| K932851 | Disposable Penile Blood Pressure CuffsDXQ · Traditional | 11/15/1993SE |
| K905367 | E-20 Rapid Cuff InflatorDXN · Traditional | 03/06/1991SE |
| K901592 | Model MD-5 DopplerDXK · Traditional | 10/22/1990SE |
Questions and answers
When was Non Invasive Vascular Program cleared by the FDA?
Non Invasive Vascular Program (K932852) received a 510(k) decision of Substantially Equivalent on February 4, 1994, 239 days after the submission was received.
What is the product code of K932852?
The FDA product code is JOB – Hexane Extraction, Fluorescence, Vitamin E, a Class I (low risk) device regulated under 21 CFR 862.1815.