The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Masterscreen Pneumo & Masterscope.
| Device ID | K071753 |
| 510k Number | K071753 |
| Device Name: | MASTERSCREEN PNEUMO & MASTERSCOPE |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| 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 | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-28 |
| Decision Date | 2007-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892901688 | K071753 | 000 |
| 34250892904925 | K071753 | 000 |
| 34250892904918 | K071753 | 000 |
| 14250892902064 | K071753 | 000 |
| 04250892904955 | K071753 | 000 |
| 04250892904931 | K071753 | 000 |
| 34250892904901 | K071753 | 000 |
| 14250892903566 | K071753 | 000 |