Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K914488 |
Device Name |
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS |
Applicant |
INVACARE CORP. |
899 CLEVELAND ST. |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Applicant Contact |
EDWARD A KROLL |
Correspondent |
INVACARE CORP. |
899 CLEVELAND ST. |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Correspondent Contact |
EDWARD A KROLL |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 10/08/1991 |
Decision Date | 09/15/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|