The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Co2/02 Monitor Multinex.
Device ID | K872024 |
510k Number | K872024 |
Device Name: | CO2/02 MONITOR MULTINEX |
Classification | Analyzer, Gas, Nitrogen, Gaseous-phase |
Applicant | DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
Contact | Arthur Friedman |
Correspondent | Arthur Friedman DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
Product Code | CCI |
CFR Regulation Number | 868.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-26 |
Decision Date | 1988-03-31 |