The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Lionheart 3 Multi-parameter Simulator.
| Device ID | K944257 |
| 510k Number | K944257 |
| Device Name: | LIONHEART 3 MULTI-PARAMETER SIMULATOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
| Contact | Michael N Sevigny |
| Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-31 |
| Decision Date | 1994-09-21 |