Infusion Dynamics Power Infuser

FDA 510(k) K974074 · Infusion Dynamics, Inc.

Substantially Equivalent

510(k) numberK974074

Submission

Device name
Infusion Dynamics Power Infuser
Applicant
Infusion Dynamics, Inc.
Princeton, NJ, US
Received
October 29, 1997
Decision date
February 17, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KZD – Infusor, Pressure, For I.V. Bags
Device class
Class I (low risk)
Regulation
21 CFR 880.5420
Specialty
General Hospital

Other 510(k)s with product code KZD

510(k)DeviceApplicantDecision
K973843Msi Pressure InfusorKZD · Traditional Smith Assoc.10/29/1997SE
K953290Olympus Automatic Surgical Irrigation PumpKZD · Traditional Olympus America, Inc.10/07/1995SE
K951988PressurizerKZD · Traditional Promedic, Inc.06/14/1995SE
K942933Pressure Infusion CuffKZD · Traditional Circulatory Technology, Inc.08/25/1994SE
K930012Kawasumi Laboratories K-CuffKZD · Traditional Kawasumi Laboratories Co., Ltd.12/14/1993SE
K921168Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional Allen Medical Systems, Inc.04/21/1993SE
K913751Pressure InfuserKZD · Traditional Biomedical Dynamics, Inc.01/09/1992SE
K910926Tecnadyne Surgi-Squeeze Infusion PumpKZD · Traditional Tecnadyne Scientific, Inc.08/02/1991SE
K911216InfusableKZD · Traditional Biomedical Dynamics, Inc.07/22/1991SE
K904484Baxter Single Patient Use Pressure InfusorKZD · Traditional Tecnadyne Scientific, Inc.10/26/1990SE

More from Tecnadyne Scientific, Inc.

510(k)DeviceDecision
K030739Infusion Dynamics (Id) Power Infuser, Model M100B-3A with Blood CartridgeFRN · Traditional 01/14/2004SE
K992044Infusion Dynamics Power Infuser Model M100BFRN · Traditional 09/08/1999SE

Questions and answers

When was Infusion Dynamics Power Infuser cleared by the FDA?

Infusion Dynamics Power Infuser (K974074) received a 510(k) decision of Substantially Equivalent on February 17, 1998, 111 days after the submission was received.

What is the product code of K974074?

The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.