| Device Classification Name |
Unit, Liquid-Oxygen, Portable
|
| 510(k) Number |
K864280 |
| Device Name |
ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT |
| Applicant |
| Smith-Taylor Mfg. Co., Div. Allied Medical Corp. |
| 3079 Mariner Way |
|
Lantana,
FL
33462
|
|
| Applicant Contact |
DAVID SMITH |
| Correspondent |
| Smith-Taylor Mfg. Co., Div. Allied Medical Corp. |
| 3079 Mariner Way |
|
Lantana,
FL
33462
|
|
| Correspondent Contact |
DAVID SMITH |
| Regulation Number | 868.5655 |
| Classification Product Code |
|
| Date Received | 10/30/1986 |
| Decision Date | 01/28/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|