The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Ipd Oxygen Conserving Device.
Device ID | K953852 |
510k Number | K953852 |
Device Name: | MODEL IPD OXYGEN CONSERVING DEVICE |
Classification | Conserver, Oxygen |
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 | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-16 |
Decision Date | 1995-11-22 |