The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph 2110 Software Interface.
| Device ID | K950854 |
| 510k Number | K950854 |
| Device Name: | VITALOGRAPH 2110 SOFTWARE INTERFACE |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Phil Hemes |
| Correspondent | Phil Hemes VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-10-12 |