The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Viewpoint Telemetry System.
| Device ID | K031760 |
| 510k Number | K031760 |
| Device Name: | VIEWPOINT TELEMETRY SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DATASCOPE CORP. 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Contact | Susan E Mandy |
| Correspondent | Susan E Mandy DATASCOPE CORP. 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-06 |
| Decision Date | 2003-10-10 |
| Summary: | summary |