The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Trio Monitor.
| Device ID | K041907 |
| 510k Number | K041907 |
| 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 | Bahram Barzideh UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-15 |
| Decision Date | 2004-07-23 |
| Summary: | summary |