The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Mobilaire V & Iii Pro2 Oxygen Sensors Features.
Device ID | K924818 |
510k Number | K924818 |
Device Name: | MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES |
Classification | Generator, 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 | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-28 |
Decision Date | 1993-08-06 |