The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for St-460 Spiro Analyzer Spirometer.
| Device ID | K852308 |
| 510k Number | K852308 |
| Device Name: | ST-460 SPIRO ANALYZER SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Contact | Mored Davoudzadeh |
| Correspondent | Mored Davoudzadeh FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-06-24 |