The following data is part of a premarket notification filed by Futuremed America, Inc. with the FDA for Spirobank Portable Pc Based Spirometer.
| Device ID | K973456 |
| 510k Number | K973456 |
| Device Name: | SPIROBANK PORTABLE PC BASED SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | FUTUREMED AMERICA, INC. 15700 DEVONSHIRE ST. Granada Hills, CA 91344 -7225 |
| Contact | Michael Davidson |
| Correspondent | Michael Davidson FUTUREMED AMERICA, INC. 15700 DEVONSHIRE ST. Granada Hills, CA 91344 -7225 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-11 |
| Decision Date | 1998-07-22 |