The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-xx.
| Device ID | K983575 |
| 510k Number | K983575 |
| Device Name: | ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1999-05-13 |