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FDA 510(k)

CARBOCONE

K-Number: K851732 · 1985-09-16

ApplicantImtech Corp.
Decision Date1985-09-16
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARBOCONE is the device name listed in this FDA 510(k) record. The listed applicant is Imtech Corp.. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K851732. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBOCONE?

CARBOCONE is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Imtech Corp.. The 510(k) number is K851732.

When did CARBOCONE receive FDA 510(k) clearance?

CARBOCONE received FDA 510(k) clearance on 1985-09-16, under 510(k) number K851732.

Who is the listed applicant for CARBOCONE?

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

What is the FDA product code for CARBOCONE?

The FDA product code for CARBOCONE is DRX.

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Related Devices (Code: DRX)

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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