The following data is part of a premarket notification filed by Viasys Respiratory Care Inc. with the FDA for Micro Diary Spirometer.
| Device ID | K100928 |
| 510k Number | K100928 |
| Device Name: | MICRO DIARY SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | VIASYS RESPIRATORY CARE INC. 22745 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Merritt Girgis |
| Correspondent | Merritt Girgis VIASYS RESPIRATORY CARE INC. 22745 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-05 |
| Decision Date | 2011-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54250892905544 | K100928 | 000 |
| 54250892902987 | K100928 | 000 |
| 54250892901157 | K100928 | 000 |