OnSite-IV

Set, I.v. Fluid Transfer

PHARMC, LLC

The following data is part of a premarket notification filed by Pharmc, Llc with the FDA for Onsite-iv.

Pre-market Notification Details

• Device ID: K161800
• 510k Number: K161800
• Device Name: OnSite-IV
• Classification: Set, I.v. Fluid Transfer
• Applicant: PHARMC, LLC 6655 NORTH VISTA LANE Jackson, WY 83001
• Contact: Chris Tice
• Correspondent: Sigi Caron; MEDTECH CONSULTANTS 20370 SKYHAWK LANE Topanga, CA 90290
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-30
• Decision Date: 2016-12-06
• Summary: summary