The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Spirovision.
| Device ID | K864885 |
| 510k Number | K864885 |
| Device Name: | SPIROVISION |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Contact | Morad Davoudzadeh |
| Correspondent | Morad Davoudzadeh FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-12 |
| Decision Date | 1987-01-15 |