Device Classification Name |
Oximeter
|
510(k) Number |
K092950 |
Device Name |
SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES |
Applicant |
SOLARIS MEDICAL TECHNOLOGY, INC. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
SOLARIS MEDICAL TECHNOLOGY, INC. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/24/2009 |
Decision Date | 03/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|