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FDA 510(k), K950388, POLARIS
FDA 510(k), K950388, POLARIS
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510(K) Number: K950388
Device Name: POLARIS
Manufacturer: SPEGAS INDUSTRIES, LTD.
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 868.1400
Classification Product Code: CCK
Date Received: 02/01/1995
Decision Date: 05/02/1995
Regulation Medical Specialty: Anesthesiology
Device Name: POLARIS
Manufacturer: SPEGAS INDUSTRIES, LTD.
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 868.1400
Classification Product Code: CCK
Date Received: 02/01/1995
Decision Date: 05/02/1995
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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