The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Calculating Cuff Inflator Td312.
| Device ID | K842067 |
| 510k Number | K842067 |
| Device Name: | CALCULATING CUFF INFLATOR TD312 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | D. E. HOKANSON, INC. 2450 NEWPORT WAY S.E. Issaquah, WA 98027 |
| Contact | Eugene Hokanson |
| Correspondent | Eugene Hokanson D. E. HOKANSON, INC. 2450 NEWPORT WAY S.E. Issaquah, WA 98027 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-23 |
| Decision Date | 1985-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817065022430 | K842067 | 000 |
| 00817065022423 | K842067 | 000 |
| 00817065022409 | K842067 | 000 |
| 00817065022386 | K842067 | 000 |
| 00817065021419 | K842067 | 000 |
| 00817065021402 | K842067 | 000 |
| 00817065021181 | K842067 | 000 |
| 00817065021129 | K842067 | 000 |
| 00817065021112 | K842067 | 000 |