The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for Automatic Spirometer St-200.
Device ID | K832433 |
510k Number | K832433 |
Device Name: | AUTOMATIC SPIROMETER ST-200 |
Classification | Spirometer, Diagnostic |
Applicant | FUTURE IMPEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-22 |
Decision Date | 1983-09-29 |