Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K851620 |
Device Name |
SPIROMED 2 |
Applicant |
DRAEGER MEDICAL, INC. |
148 B. QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
EDWARD T GRIFFITH |
Correspondent |
DRAEGER MEDICAL, INC. |
148 B. QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
EDWARD T GRIFFITH |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 04/18/1985 |
Decision Date | 05/10/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|