| Device Classification Name |
gas-machine, anesthesia |
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|---|---|---|---|---|
| 510(k) Number | K992421 | |||
| Device Name | GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 | |||
| Applicant |
|
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| Applicant Contact | dottie knechtel | |||
| Correspondent |
|
|||
| Correspodent 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 |