The following data is part of a premarket notification filed by Cosmed S.r.l. with the FDA for Spiropalm.
| Device ID | K093174 |
| 510k Number | K093174 |
| Device Name: | SPIROPALM |
| Classification | Spirometer, Diagnostic |
| Applicant | COSMED S.R.L. 1129 BLOOMFIELD AVENUE SUITE 202 West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff COSMED S.R.L. 1129 BLOOMFIELD AVENUE SUITE 202 West Caldwell, NJ 07006 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-08 |
| Decision Date | 2010-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052400180096 | K093174 | 000 |
| 18052400180072 | K093174 | 000 |