The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope 6000 Monitor.
Device ID | K926099 |
510k Number | K926099 |
Device Name: | DATASCOPE 6000 MONITOR |
Classification | Monitor, St Segment |
Applicant | DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
Contact | Michael Barile |
Correspondent | Michael Barile DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
Product Code | MLC |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-03 |
Decision Date | 1993-08-06 |