The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Trio Monitor.
| Device ID | K051897 |
| 510k Number | K051897 |
| Device Name: | TRIO MONITOR |
| Classification | Monitor, Physiological, Patient (without 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 | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-13 |
| Decision Date | 2005-08-12 |