The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Ecg Simulator Model Ecgplus.
| Device ID | K893660 |
| 510k Number | K893660 |
| Device Name: | ECG SIMULATOR MODEL ECGPLUS |
| Classification | Electrocardiograph |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Contact | Dan Contois |
| Correspondent | Dan Contois BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-12-05 |