Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K091650 |
Device Name |
AXS-590 SERIES |
Applicant |
SWR INTERNATIONAL, LTD |
161 LITTLE BAY ROAD |
NEWINGTON,
NH
03801
|
|
Applicant Contact |
MARTIN J LEIGHTON |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 06/09/2009 |
Decision Date | 11/24/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|