Light Reflection Rheography

FDA 510(k) K852378 · Hemodynamics, Inc.

Substantially Equivalent

510(k) numberK852378

Submission

Device name
Light Reflection Rheography
Applicant
Hemodynamics, Inc.
Boca Raton, FL, US
Received
June 5, 1985
Decision date
June 20, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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Questions and answers

When was Light Reflection Rheography cleared by the FDA?

Light Reflection Rheography (K852378) received a 510(k) decision of Substantially Equivalent on June 20, 1985, 15 days after the submission was received.

What is the product code of K852378?

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