The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Multinex Id Plus.
Device ID | K930303 |
510k Number | K930303 |
Device Name: | DATASCOPE MULTINEX ID PLUS |
Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
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 | CBQ |
CFR Regulation Number | 868.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-21 |
Decision Date | 1993-06-16 |