The following data is part of a premarket notification filed by Zoll Manufacturing Corporation with the FDA for µcor Heart Failure And Arrhythmia Management System.
| Device ID | K172510 |
| 510k Number | K172510 |
| Device Name: | µCor Heart Failure And Arrhythmia Management System |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ZOLL Manufacturing Corporation 121 Gamma Drive Pittsburgh, PA 15238 |
| Contact | Dawn Chang |
| Correspondent | Dawn Chang ZOLL Manufacturing Corporation 2000 Ringwood Avenue San Jose, CA 95131 |
| Product Code | MHX |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2018-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855778005326 | K172510 | 000 |
| 00855778005319 | K172510 | 000 |
| 00855778005302 | K172510 | 000 |
| 00855778005258 | K172510 | 000 |
| 00855778005456 | K172510 | 000 |