| 510(k) Number |
K822719 |
| Device Name |
ERIE OXYGEN CONCENTRATOR |
| Applicant |
| Erie Controls |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Erie Controls |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Date Received | 09/07/1982 |
| Decision Date | 09/28/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|