INSTAPURE

Cleaner, Air, Medical Recirculating

TELEDYNE, INC.

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

Pre-market Notification Details

• Device ID: K854817
• 510k Number: K854817
• Device Name: INSTAPURE
• Classification: Cleaner, Air, Medical Recirculating
• Applicant: TELEDYNE, INC. 1730 EAST PROSPECT ST. Fort Collins, CO 80525
• Contact: Donald W Ruehmann
• Correspondent: Donald W Ruehmann; TELEDYNE, INC. 1730 EAST PROSPECT ST. Fort Collins, CO 80525
• Product Code: FRF
• CFR Regulation Number: 880.5045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-12-03
• Decision Date: 1986-02-28