The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Gas Module Ii, Model 0998-00-0143.
| Device ID | K974903 |
| 510k Number | K974903 |
| Device Name: | GAS MODULE II, MODEL 0998-00-0143 |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-31 |
| Decision Date | 1998-03-13 |