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 |