Iq System

FDA 510(k) K981720 · Renaissance Technology, Inc.

Substantially Equivalent

510(k) numberK981720

Submission

Device name
Iq System
Applicant
Renaissance Technology, Inc.
Newtown, PA, US
Received
May 5, 1998
Decision date
February 8, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DSB – Plethysmograph, Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

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More from Zynex Medical, Inc.

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Questions and answers

When was Iq System cleared by the FDA?

Iq System (K981720) received a 510(k) decision of Substantially Equivalent on February 8, 1999, 279 days after the submission was received.

What is the product code of K981720?

The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.