The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Masterscreen Cpx And Oxycon Cpx.
| Device ID | K040698 |
| 510k Number | K040698 |
| Device Name: | MASTERSCREEN CPX AND OXYCON CPX |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | VIASYS HEALTHCARE GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Edmond Chu |
| Correspondent | Edmond Chu VIASYS HEALTHCARE GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-17 |
| Decision Date | 2004-04-07 |