The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Mobilaire Liquid Oxygen Systems.
Device ID | K926267 |
510k Number | K926267 |
Device Name: | MOBILAIRE LIQUID OXYGEN SYSTEMS |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-18 |
Decision Date | 1993-08-31 |