The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Ecg Monitor And Respiration Pacer.
| Device ID | K881055 |
| 510k Number | K881055 |
| Device Name: | ECG MONITOR AND RESPIRATION PACER |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-08-19 |