The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Netguard Automated Clinician Alert System, Model 0998-00-1600-xx.
| Device ID | K071805 |
| 510k Number | K071805 |
| Device Name: | NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | DATASCOPE CORP. 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Contact | Kathleen Kramer |
| Correspondent | Kathleen Kramer DATASCOPE CORP. 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-09-25 |
| Summary: | summary |