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 |