The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Passport 2 Vital Signs Monitor, Model 0998-00-0170-xx.
| Device ID | K993531 |
| 510k Number | K993531 |
| Device Name: | PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. Paramus, NJ 07652 |
| Contact | Susan E Mandy |
| Correspondent | Susan E Mandy DATASCOPE CORP. 580 WINTERS AVE. Paramus, NJ 07652 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 2000-01-13 |
| Summary: | summary |