LYTENING 1

Electrode, Ion Specific, Sodium

AMDEV, INC.

The following data is part of a premarket notification filed by Amdev, Inc. with the FDA for Lytening 1.

Pre-market Notification Details

• Device ID: K853832
• 510k Number: K853832
• Device Name: LYTENING 1
• Classification: Electrode, Ion Specific, Sodium
• Applicant: AMDEV, INC. 40 ROGERS RD. WALL HILL INDUSTRIAL PARK Haverhill, MA 01830
• Contact: Donald Schwartz
• Correspondent: Donald Schwartz; AMDEV, INC. 40 ROGERS RD. WALL HILL INDUSTRIAL PARK Haverhill, MA 01830
• Product Code: JGS
• CFR Regulation Number: 862.1665 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-09-13
• Decision Date: 1985-10-04