The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Cardioconfirm.
| Device ID | K161465 |
| 510k Number | K161465 |
| Device Name: | CardioConfirm |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH STREET Milwaukee, WI 53224 |
| Contact | Margaret Mucha |
| Correspondent | Margaret Mucha MORTARA INSTRUMENT, INC. 7865 NORTH 86TH STREET Milwaukee, WI 53224 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-27 |
| Decision Date | 2016-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345024715 | K161465 | 000 |
| 00812345024708 | K161465 | 000 |
| 00817655022772 | K161465 | 000 |
| 00817655022765 | K161465 | 000 |
| 00817655020259 | K161465 | 000 |
| 00817655020242 | K161465 | 000 |