The following data is part of a premarket notification filed by Linde Gas Therapeutics with the FDA for Linde Integrated Valve (liv).
| Device ID | K063354 |
| 510k Number | K063354 |
| Device Name: | LINDE INTEGRATED VALVE (LIV) |
| Classification | Cylinder, Compressed Gas, And Valve |
| Applicant | LINDE GAS THERAPEUTICS P.O. BOX 470218 Broadview Heights, OH 44147 |
| Contact | James J Rogers |
| Correspondent | James J Rogers LINDE GAS THERAPEUTICS P.O. BOX 470218 Broadview Heights, OH 44147 |
| Product Code | ECX |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2007-04-17 |
| Summary: | summary |