FDA 510(k)

STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)

K-Number: K040240 · 2004-04-01

Decision Date2004-04-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) is the device name listed in this FDA 510(k) record. The listed applicant is Stellartech Research Corp.. It received FDA 510(k) clearance on 2004-04-01 under 510(k) number K040240. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)?

STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) is a medical device that received FDA 510(k) clearance on 2004-04-01. The listed applicant is Stellartech Research Corp.. The 510(k) number is K040240.

When did STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) receive FDA 510(k) clearance?

STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) received FDA 510(k) clearance on 2004-04-01, under 510(k) number K040240.

Who is the listed applicant for STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)?

The FDA 510(k) record lists Stellartech Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)?

The FDA product code for STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) is GEI.

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Other records listing Stellartech Research Corp. as applicant

K061544STELLARTECH 100 COAGULATION SYSTEM K050831STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A K042909STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A K041383STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 K032721MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)K032452MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230

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Official Source

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