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FDA 510(k)

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

K-Number: K032062 · 2003-07-29

ApplicantStellartech Research Corp.
Decision Date2003-07-29
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 2003-07-29 under 510(k) number K032062. 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 2003-07-29. The listed applicant is Stellartech Research Corp.. The 510(k) number is K032062.

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 2003-07-29, under 510(k) number K032062.

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

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.

K061544STELLARTECH 100 COAGULATION SYSTEMK050831STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230AK042909STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230AK041383STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230K040240STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)K032721MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)

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Related Devices (Code: GEI)

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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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