The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Disposable Penile Blood Pressure Cuffs.
Device ID | K932851 |
510k Number | K932851 |
Device Name: | DISPOSABLE PENILE BLOOD PRESSURE CUFFS |
Classification | Device, Erectile Dysfunction |
Applicant | D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
Contact | Eugene Hokanson |
Correspondent | Eugene Hokanson D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
Product Code | LST |
Subsequent Product Code | DXN |
Subsequent Product Code | DXQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-10 |
Decision Date | 1993-11-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817065022362 | K932851 | 000 |
00817065022300 | K932851 | 000 |
00817065021709 | K932851 | 000 |
00817065021495 | K932851 | 000 |
00817065020917 | K932851 | 000 |
00817065020870 | K932851 | 000 |
00817065020832 | K932851 | 000 |
00817065022508 | K932851 | 000 |