The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for E-20 Rapid Cuff Inflator.
| Device ID | K905367 |
| 510k Number | K905367 |
| Device Name: | E-20 RAPID CUFF INFLATOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-27 |
| Decision Date | 1991-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817065021273 | K905367 | 000 |
| 00817065021266 | K905367 | 000 |
| 00817065021259 | K905367 | 000 |
| 00817065021242 | K905367 | 000 |
| 00817065021235 | K905367 | 000 |
| 00817065021228 | K905367 | 000 |