Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K864806 |
Device Name |
ANESTHESIA RECORDER |
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 | 868.5160
|
Classification Product Code |
|
Date Received | 12/09/1986 |
Decision Date | 01/15/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|