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FDA 510(k)

MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230

K-Number: K032452 · 2003-08-21

ApplicantStellartech Research Corp.
Decision Date2003-08-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-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 2003-08-21 under 510(k) number K032452. 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 MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230?

MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is Stellartech Research Corp.. The 510(k) number is K032452.

When did MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 receive FDA 510(k) clearance?

MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 received FDA 510(k) clearance on 2003-08-21, under 510(k) number K032452.

Who is the listed applicant for MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-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 MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230?

The FDA product code for MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-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)

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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