Device Classification Name |
Conserver, Oxygen
|
510(k) Number |
K001412 |
Device Name |
PM 1800 CONSERVING DEVICE |
Applicant |
PRECISION MEDICAL, INC. |
300 HELD DR. |
NORTHAMPTON,
PA
18067
|
|
Applicant Contact |
CONLEY WALLACE |
Correspondent |
PRECISION MEDICAL, INC. |
300 HELD DR. |
NORTHAMPTON,
PA
18067
|
|
Correspondent Contact |
CONLEY WALLACE |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 05/04/2000 |
Decision Date | 03/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|