The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Ans 2000 Ecg Monitor And Respiration Pacer.
| Device ID | K973426 |
| 510k Number | K973426 |
| Device Name: | ANS 2000 ECG MONITOR AND RESPIRATION PACER |
| Classification | Electrocardiograph |
| Applicant | D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
| Contact | D. Eugene Hokanson |
| Correspondent | D. Eugene Hokanson D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue, WA 98005 -1910 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1998-08-12 |