The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-xx).
| Device ID | K970061 |
| 510k Number | K970061 |
| Device Name: | ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) |
| Classification | Oximeter |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. Paramus, NJ 07653 |
| Contact | Frank Casamssina |
| Correspondent | Frank Casamssina DATASCOPE CORP. 580 WINTERS AVE. Paramus, NJ 07653 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-07 |
| Decision Date | 1997-09-25 |