Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K022031 |
Device Name |
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 |
Applicant |
DRAEGER MEDICAL, INC. |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
MICHAEL A KELHART |
Correspondent |
DRAEGER MEDICAL, INC. |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
MICHAEL A KELHART |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 06/21/2002 |
Decision Date | 08/29/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|