The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Instrument Model X-scribe (treadmill Included).
| Device ID | K900720 |
| 510k Number | K900720 |
| Device Name: | MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | `ohn Primozich |
| Correspondent | `ohn Primozich MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-14 |
| Decision Date | 1990-11-05 |