The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Passport 2 With View 12 Ecg Analysis Module Model # 0998-00-0170-xxxx.
| Device ID | K020550 |
| 510k Number | K020550 |
| Device Name: | PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | DATASCOPE CORP. 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen DATASCOPE CORP. 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-08-28 |
| Summary: | summary |