The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Passport 5l-ce Model 0998-00-0131xxx.
| Device ID | K974178 |
| 510k Number | K974178 |
| Device Name: | PASSPORT 5L-CE MODEL 0998-00-0131XXX |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-06 |
| Decision Date | 1998-06-26 |