Jobst Athrombic Pump - System 2500

FDA 510(k) K934639 · Jobst Institute, Inc.

Substantially Equivalent

510(k) numberK934639

Submission

Device name
Jobst Athrombic Pump - System 2500
Applicant
Jobst Institute, Inc.
Charlotte, NC, US
Received
September 29, 1993
Decision date
February 9, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

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Questions and answers

When was Jobst Athrombic Pump - System 2500 cleared by the FDA?

Jobst Athrombic Pump - System 2500 (K934639) received a 510(k) decision of Substantially Equivalent on February 9, 1994, 133 days after the submission was received.

What is the product code of K934639?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.