The following data is part of a premarket notification filed by Schiller Ag with the FDA for Spirovit Sp-2, Pneumocheck Ii.
| Device ID | K992823 |
| 510k Number | K992823 |
| Device Name: | SPIROVIT SP-2, PNEUMOCHECK II |
| Classification | Spirometer, Diagnostic |
| Applicant | SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
| Contact | Markus Buetler |
| Correspondent | Markus Buetler SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-23 |
| Decision Date | 2000-05-12 |
| Summary: | summary |