MTP E.V. INFUSION PUMP

Pump, Infusion

ZIEHM INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Mtp E.v. Infusion Pump.

Pre-market Notification Details

• Device ID: K842263
• 510k Number: K842263
• Device Name: MTP E.V. INFUSION PUMP
• Classification: Pump, Infusion
• Applicant: ZIEHM INTERNATIONAL, INC. 2012 RENARD CT., UNIT A & D Annapolis, MD 21401
• Product Code: FRN
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-06-07
• Decision Date: 1984-07-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18500042541015	K842263	000