The following data is part of a premarket notification filed by Marquette Medical Systems, Inc. with the FDA for Rac 2a Module Housing.
| Device ID | K973984 |
| 510k Number | K973984 |
| Device Name: | RAC 2A MODULE HOUSING |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MARQUETTE MEDICAL SYSTEMS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Dianne Schmitz |
| Correspondent | Dianne Schmitz MARQUETTE MEDICAL SYSTEMS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-20 |
| Decision Date | 1998-01-16 |
| Summary: | summary |