The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for A16 Blood Flow Measurement System.
| Device ID | K023707 |
| 510k Number | K023707 |
| Device Name: | A16 BLOOD FLOW MEASUREMENT SYSTEM |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
| Contact | D. Eugene Hokanson |
| Correspondent | D. Eugene Hokanson D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-04 |
| Decision Date | 2003-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817065022454 | K023707 | 000 |
| 00817065021396 | K023707 | 000 |
| 00817065021211 | K023707 | 000 |