Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K991412 |
Device Name |
VITALOGRAPH MICRO |
Applicant |
VITALOGRAPH, INC. |
8347 QUIVIRA RD. |
LENEXA,
KS
66215
|
|
Applicant Contact |
PHIL HEMES |
Correspondent |
VITALOGRAPH, INC. |
8347 QUIVIRA RD. |
LENEXA,
KS
66215
|
|
Correspondent Contact |
PHIL HEMES |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 04/23/1999 |
Decision Date | 02/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|