Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K014078 |
Device Name |
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM |
Applicant |
ON SITE GAS SYSTEMS, INC. |
100 PRODUCTION COURT |
NEW BRITAIN,
CT
06051
|
|
Applicant Contact |
C. BARTON GULLONG |
Correspondent |
ON SITE GAS SYSTEMS, INC. |
100 PRODUCTION COURT |
NEW BRITAIN,
CT
06051
|
|
Correspondent Contact |
C. BARTON GULLONG |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 12/11/2001 |
Decision Date | 01/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|