FDA 510(k), K950388, POLARIS

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

Total pages: 583
Fully redacted pages: 436
Content pages: 147