Device Classification Name |
unit, liquid-oxygen, portable
|
510(k) Number |
K103324 |
Device Name |
PRECISION LIQUID OXYGEN SYSTEM |
Applicant |
PRECISION MEDICAL, INC. |
300 HELD DRIVE |
NORTHAMPTON,
PA
18067
|
|
Applicant Contact |
JAMES PARKER |
Correspondent |
PRECISION MEDICAL, INC. |
300 HELD DRIVE |
NORTHAMPTON,
PA
18067
|
|
Correspondent Contact |
JAMES PARKER |
Regulation Number | 868.5655
|
Classification Product Code |
|
Date Received | 11/12/2010 |
Decision Date | 04/21/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|