Device Classification Name |
Oximeter
|
510(k) Number |
K092641 |
Device Name |
CHARMCARE TABLETOP PULSE OXIMETER |
Applicant |
CHARMCARE CO., LTD |
325 N. PUENTE ST. |
UNIT B |
BREA,
CA
92821
|
|
Applicant Contact |
JOYCE BANG |
Correspondent |
CHARMCARE CO., LTD |
325 N. PUENTE ST. |
UNIT B |
BREA,
CA
92821
|
|
Correspondent Contact |
JOYCE BANG |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/27/2009 |
Decision Date | 10/21/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|