The following data is part of a premarket notification filed by Futuremed America, Inc. with the FDA for Spirovision Sv-iii Pc Based Spirometer Kit Micro.
| Device ID | K953948 |
| 510k Number | K953948 |
| Device Name: | SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO |
| Classification | Spirometer, Diagnostic |
| Applicant | FUTUREMED AMERICA, INC. 21732 DEVONSHIRE ST. Chatsworth, CA 91313 |
| Contact | Michael Davidson |
| Correspondent | Michael Davidson FUTUREMED AMERICA, INC. 21732 DEVONSHIRE ST. Chatsworth, CA 91313 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-16 |
| Decision Date | 1996-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853452007024 | K953948 | 000 |