Device Classification Name |
Spirometer, Monitoring (W/Wo Alarm)
|
510(k) Number |
K863538 |
Device Name |
RESPICENTRAL(TM) |
Applicant |
DICKSTEIN, SHAPIRO & MORIN |
2101 L STREET, N.W. |
WASHINGTON,
DC
20037
|
|
Applicant Contact |
RODNEY R MUNSEY |
Correspondent |
DICKSTEIN, SHAPIRO & MORIN |
2101 L STREET, N.W. |
WASHINGTON,
DC
20037
|
|
Correspondent Contact |
RODNEY R MUNSEY |
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 09/11/1986 |
Decision Date | 09/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|