The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for St-90 Spiro Analizer.
| Device ID | K861487 |
| 510k Number | K861487 |
| Device Name: | ST-90 SPIRO ANALIZER |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
| Contact | Morad Davoudzadeh |
| Correspondent | Morad Davoudzadeh FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-11 |
| Decision Date | 1986-06-23 |