The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Trio Monitor Model 0998-00-0600.
| Device ID | K032338 |
| 510k Number | K032338 |
| Device Name: | TRIO MONITOR MODEL 0998-00-0600 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-29 |
| Decision Date | 2004-02-11 |
| Summary: | summary |