Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K040723 |
Device Name |
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) |
Applicant |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 03/22/2004 |
Decision Date | 06/10/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|