Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase |
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510(k) Number | K954402 | |||
Device Name | ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | |||
Applicant |
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Applicant Contact | andras gedeon | |||
Correspondent |
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Correspodent Contact | andras gedeon | |||
Regulation Number | 868.1400 | |||
Classification Product Code |
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Date Received | 09/20/1995 | |||
Decision Date | 05/22/1996 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Anesthesiology |
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510k Review Panel |
Anesthesiology |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |