ASTRA

Ph Rate Measurement, Carbon-dioxide

CHEM-ELEC, INC.

The following data is part of a premarket notification filed by Chem-elec, Inc. with the FDA for Astra.

Pre-market Notification Details

• Device ID: K811381
• 510k Number: K811381
• Device Name: ASTRA
• Classification: Ph Rate Measurement, Carbon-dioxide
• Applicant: CHEM-ELEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JFL
• CFR Regulation Number: 862.1160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-05-15
• Decision Date: 1981-08-13