The following data is part of a premarket notification filed by Cosmed S.r.l. with the FDA for Quark Series.
| Device ID | K120146 |
| 510k Number | K120146 |
| Device Name: | QUARK SERIES |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | COSMED S.R.L. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07000 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff COSMED S.R.L. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07000 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052400180355 | K120146 | 000 |
| 18052400180188 | K120146 | 000 |
| 18052400180171 | K120146 | 000 |
| 18052400180164 | K120146 | 000 |
| 18052400180065 | K120146 | 000 |