Scanmate III

FDA 510(k) K921878 · Circadian, Inc.

Substantially Equivalent

510(k) numberK921878

Submission

Device name
Scanmate III
Applicant
Circadian, Inc.
San Leandro, CA, US
Received
April 20, 1992
Decision date
September 11, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYP – Phantom, Anthropomorphic, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1370
Specialty
Radiology

Other 510(k)s with product code IYP

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K844189Linear Scanner Probe Elscint Ltd. TL-35IYP · Traditional Elscint, Inc.02/25/1985SE
K812893SuperflabIYP · Traditional Mick Radio-Nuclear Instruments, Inc.12/08/1981SE

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K860973Circadian Stress Test SystemDPS · Traditional 08/25/1986SE
K851517Circa Med Single-Channel-Ambulatory Cardiac MonitoDSI · Traditional 10/02/1985SE
K851643Remote Control ModuleDPS · Traditional 09/09/1985SE
K840741Pulmonary Function Testing STSBZG · Traditional 03/05/1984SE
K833619Conductance MeterKRC · Traditional 01/27/1984SE
K830830Circa Med Two-ChannelDSI · Traditional 06/18/1983SE

Questions and answers

When was Scanmate III cleared by the FDA?

Scanmate III (K921878) received a 510(k) decision of Substantially Equivalent on September 11, 1992, 144 days after the submission was received.

What is the product code of K921878?

The FDA product code is IYP – Phantom, Anthropomorphic, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1370.