POLARIS

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

SPEGAS INDUSTRIES, LTD.

The following data is part of a premarket notification filed by Spegas Industries, Ltd. with the FDA for Polaris.

Pre-market Notification Details

• Device ID: K950388
• 510k Number: K950388
• Device Name: POLARIS
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: SPEGAS INDUSTRIES, LTD. 7 HAMARPEH ST., P.O. BOX 45025 91450 Jerusalem, IL 91450
• Contact: Saan Brown
• Correspondent: Saan Brown; SPEGAS INDUSTRIES, LTD. 7 HAMARPEH ST., P.O. BOX 45025 91450 Jerusalem, IL 91450
• Product Code: CCK
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-02-01
• Decision Date: 1995-05-02