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FDA 510(k)

STERITEC EMU-GRAPH, MODEL NO. CI 131/US

K-Number: K040901 · 2004-09-09

ApplicantSteritec Products, Inc.
Decision Date2004-09-09
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERITEC EMU-GRAPH, MODEL NO. CI 131/US 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 2004-09-09 under 510(k) number K040901. 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 STERITEC EMU-GRAPH, MODEL NO. CI 131/US?

STERITEC EMU-GRAPH, MODEL NO. CI 131/US is a medical device that received FDA 510(k) clearance on 2004-09-09. The listed applicant is Steritec Products, Inc.. The 510(k) number is K040901.

When did STERITEC EMU-GRAPH, MODEL NO. CI 131/US receive FDA 510(k) clearance?

STERITEC EMU-GRAPH, MODEL NO. CI 131/US received FDA 510(k) clearance on 2004-09-09, under 510(k) number K040901.

Who is the listed applicant for STERITEC EMU-GRAPH, MODEL NO. CI 131/US?

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 STERITEC EMU-GRAPH, MODEL NO. CI 131/US?

The FDA product code for STERITEC EMU-GRAPH, MODEL NO. CI 131/US is JOJ.

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Other records listing Steritec Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083650EMU-GRAPH 4 EMULATOR, MODEL CI 144K080136INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105K052516STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137K024293BOWIE-DICK MINI PAK, MODEL BD 115K012732INTEGRAPH FLASH, MODEL CI 110K010534CROSS-CHECKS DUAL, MODEL CI 125

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Related Devices (Code: JOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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