The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Masterscreen Pft, Masterscreen Pft Ct, Masterscreen Pft Body.
| Device ID | K072061 |
| 510k Number | K072061 |
| Device Name: | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY |
| Classification | Plethysmograph, Volume |
| Applicant | VIASYS HEALTHCARE GMBH 22745 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd VIASYS HEALTHCARE GMBH 22745 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | JEH |
| CFR Regulation Number | 868.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-27 |
| Decision Date | 2008-04-22 |