The following data is part of a premarket notification filed by Datascope Corp., Patient Monitoring Division with the FDA for Accutorr V Monitor, Model 0998-00-2000.
| Device ID | K091068 |
| 510k Number | K091068 |
| Device Name: | ACCUTORR V MONITOR, MODEL 0998-00-2000 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | DATASCOPE CORP., PATIENT MONITORING DIVISION 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Contact | Kathleen Kramer |
| Correspondent | Kathleen Kramer DATASCOPE CORP., PATIENT MONITORING DIVISION 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-05-08 |
| Summary: | summary |