Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K031024 |
Device Name |
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 |
Applicant |
MICROLIFE CORP. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
MICROLIFE CORP. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 03/31/2003 |
Decision Date | 11/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|