The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Upgraded Spirometer St-90.
| Device ID | K933511 |
| 510k Number | K933511 |
| Device Name: | UPGRADED SPIROMETER ST-90 |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Contact | Michael Davidson |
| Correspondent | Michael Davidson FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, 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 | 1993-07-15 |
| Decision Date | 1994-02-10 |