Lawrence L3000 Cardiac Output Monitor

FDA 510(k) K874885 · Lawrence Medical Systems, Inc.

Substantially Equivalent

510(k) numberK874885

Submission

Device name
Lawrence L3000 Cardiac Output Monitor
Applicant
Lawrence Medical Systems, Inc.
Cammarillo, CA, US
Received
December 1, 1987
Decision date
February 5, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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K874492Lawrence L4000 Reflectance Pulse OximeterDQA · Traditional 03/22/1988SE
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K851426Accucom Cardiac Output MonitorDXK · Traditional 07/12/1985SE

Questions and answers

When was Lawrence L3000 Cardiac Output Monitor cleared by the FDA?

Lawrence L3000 Cardiac Output Monitor (K874885) received a 510(k) decision of Substantially Equivalent on February 5, 1988, 66 days after the submission was received.

What is the product code of K874885?

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