The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Ecg Review Station.
| Device ID | K942685 |
| 510k Number | K942685 |
| Device Name: | ECG REVIEW STATION |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Larry A Lepley |
| Correspondent | Larry A Lepley MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-07 |
| Decision Date | 1997-08-12 |
| Summary: | summary |