The following data is part of a premarket notification filed by Vyaire Medical, Inc. with the FDA for Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextrude.
| Device ID | K171678 |
| 510k Number | K171678 |
| Device Name: | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextrude |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Vyaire Medical, Inc. Kuortaneenkatu 2 Helsinki, FI Fin-00510 |
| Contact | Leo Sohlberg |
| Correspondent | Colleen O'keefe Vyaire Medical, Inc 26125 N. Riverwoods Blvd. Mettawa, IL 60045 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-06 |
| Decision Date | 2018-04-30 |
| Summary: | summary |