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FDA 510(k)

TITAN GE/IEPLATE

K-Number: K831603 · 1983-07-07

ApplicantHelena Laboratories
Decision Date1983-07-07
Product CodeJZR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TITAN GE/IEPLATE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831603. The device is classified under product code JZR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GE/IEPLATE?

TITAN GE/IEPLATE is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Helena Laboratories. The 510(k) number is K831603.

When did TITAN GE/IEPLATE receive FDA 510(k) clearance?

TITAN GE/IEPLATE received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831603.

Who is the listed applicant for TITAN GE/IEPLATE?

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

What is the FDA product code for TITAN GE/IEPLATE?

The FDA product code for TITAN GE/IEPLATE is JZR.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: JZR)

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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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