Device Classification Name |
filter, bacterial, breathing-circuit
|
510(k) Number |
K072002 |
Device Name |
FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 |
Applicant |
DRAEGER MEDICAL AG & CO. KG |
3135 Quarry Road |
Telford,
PA
18969
|
|
Applicant Contact |
KATHY ANDERSON |
Correspondent |
DRAEGER MEDICAL AG & CO. KG |
3135 Quarry Road |
Telford,
PA
18969
|
|
Correspondent Contact |
KATHY ANDERSON |
Regulation Number | 868.5260
|
Classification Product Code |
|
Date Received | 07/23/2007 |
Decision Date | 01/31/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|