A16 Blood Flow Measurement System
FDA 510(k) K023707 · D. E. Hokanson, Inc.
510(k) numberK023707
Submission
- Device name
- A16 Blood Flow Measurement System
- Applicant
- D. E. Hokanson, Inc.
Bellevue, WA, US - Received
- November 4, 2002
- Decision date
- February 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2780
- Specialty
- Cardiovascular
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Questions and answers
When was A16 Blood Flow Measurement System cleared by the FDA?
A16 Blood Flow Measurement System (K023707) received a 510(k) decision of Substantially Equivalent on February 12, 2003, 100 days after the submission was received.
What is the product code of K023707?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.