The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Schiller Model Sp-100 Spirovit(tm).
| Device ID | K896120 |
| 510k Number | K896120 |
| Device Name: | SCHILLER MODEL SP-100 SPIROVIT(TM) |
| Classification | Spirometer, Diagnostic |
| Applicant | SCHILLER AMERICA, INC. 3002 DOW AVENUE #122 Tustin, CA 92680 |
| Contact | J Fletcher |
| Correspondent | J Fletcher SCHILLER AMERICA, INC. 3002 DOW AVENUE #122 Tustin, CA 92680 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-24 |
| Decision Date | 1990-01-09 |