Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K992421 |
Device Name |
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 |
Applicant |
ACCUTRON, INC. |
2020 WEST MELINDA LN. |
PHOENIX,
AZ
85027
|
|
Applicant Contact |
DOTTIE KNECHTEL |
Correspondent |
ACCUTRON, INC. |
2020 WEST MELINDA LN. |
PHOENIX,
AZ
85027
|
|
Correspondent Contact |
DOTTIE KNECHTEL |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 07/21/1999 |
Decision Date | 10/27/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|