The following data is part of a premarket notification filed by Schiller Ag with the FDA for Spirovit, Model Sp-250.
| Device ID | K984031 |
| 510k Number | K984031 |
| Device Name: | SPIROVIT, MODEL SP-250 |
| 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 | 1998-11-12 |
| Decision Date | 1999-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365000108 | K984031 | 000 |