STANDEX

Exerciser, Non-measuring

ALT, INC.

The following data is part of a premarket notification filed by Alt, Inc. with the FDA for Standex.

Pre-market Notification Details

• Device ID: K885343
• 510k Number: K885343
• Device Name: STANDEX
• Classification: Exerciser, Non-measuring
• Applicant: ALT, INC. 913 SOUTH WASHINGTON Redwood Falls, MN 56283
• Contact: Alan Tholkes
• Correspondent: Alan Tholkes; ALT, INC. 913 SOUTH WASHINGTON Redwood Falls, MN 56283
• Product Code: ION
• CFR Regulation Number: 890.5370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-12-28
• Decision Date: 1989-05-01