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FDA 510(k)

EMU-GRAPH 4 EMULATOR, MODEL CI 144

K-Number: K083650 · 2009-03-05

ApplicantSteritec Products, Inc.
Decision Date2009-03-05
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMU-GRAPH 4 EMULATOR, MODEL CI 144 is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products, Inc.. It received FDA 510(k) clearance on 2009-03-05 under 510(k) number K083650. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMU-GRAPH 4 EMULATOR, MODEL CI 144?

EMU-GRAPH 4 EMULATOR, MODEL CI 144 is a medical device that received FDA 510(k) clearance on 2009-03-05. The listed applicant is Steritec Products, Inc.. The 510(k) number is K083650.

When did EMU-GRAPH 4 EMULATOR, MODEL CI 144 receive FDA 510(k) clearance?

EMU-GRAPH 4 EMULATOR, MODEL CI 144 received FDA 510(k) clearance on 2009-03-05, under 510(k) number K083650.

Who is the listed applicant for EMU-GRAPH 4 EMULATOR, MODEL CI 144?

The FDA 510(k) record lists Steritec Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMU-GRAPH 4 EMULATOR, MODEL CI 144?

The FDA product code for EMU-GRAPH 4 EMULATOR, MODEL CI 144 is JOJ.

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Other records listing Steritec Products, Inc. as applicant

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Related Devices (Code: JOJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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