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 |