Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K914085 |
Device Name |
HMS-5000 |
Applicant |
VITALOG MONITORING,INC. |
643 BAIR ISLAND RD.,STE.300 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
LAUGHTON E MILES |
Correspondent |
VITALOG MONITORING,INC. |
643 BAIR ISLAND RD.,STE.300 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
LAUGHTON E MILES |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 09/06/1991 |
Decision Date | 11/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|