Device Classification Name |
condenser, heat and moisture (artificial nose)
|
510(k) Number |
K954194 |
Device Name |
DISPOSABLE HME/FILTER |
Applicant |
ENGSTROM MEDICAL |
67920 KLINGER LAKE RD. |
STURGIS,
MI
49091 -9288
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
ENGSTROM MEDICAL |
67920 KLINGER LAKE RD. |
STURGIS,
MI
49091 -9288
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 868.5375
|
Classification Product Code |
|
Date Received | 09/06/1995 |
Decision Date | 10/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|