Jostra HL-20 Twin Pump

FDA 510(k) K984338 · Jostra Bentley

Substantially Equivalent

510(k) numberK984338

Submission

Device name
Jostra HL-20 Twin Pump
Applicant
Jostra Bentley
Oxford, PA, US
Received
December 3, 1998
Decision date
August 19, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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More from Remington Medical, Inc.

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Questions and answers

When was Jostra HL-20 Twin Pump cleared by the FDA?

Jostra HL-20 Twin Pump (K984338) received a 510(k) decision of Substantially Equivalent on August 19, 1999, 259 days after the submission was received.

What is the product code of K984338?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.