The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Instrument St Central Station.
| Device ID | K922927 |
| 510k Number | K922927 |
| Device Name: | MORTARA INSTRUMENT ST CENTRAL STATION |
| Classification | Electrocardiograph |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Lori A Dummer |
| Correspondent | Lori A Dummer MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-17 |
| Decision Date | 1992-11-10 |