The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Polyurethane Blood Pressure Cuffs.
Device ID | K041689 |
510k Number | K041689 |
Device Name: | POLYURETHANE BLOOD PRESSURE CUFFS |
Classification | Blood Pressure Cuff |
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 | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-22 |
Decision Date | 2004-08-06 |