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FDA 510(k)

TECA MONTAGE II

K-Number: K851232 · 1985-06-13

ApplicantTeca, Inc.
Decision Date1985-06-13
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA MONTAGE II is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1985-06-13 under 510(k) number K851232. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA MONTAGE II?

TECA MONTAGE II is a medical device that received FDA 510(k) clearance on 1985-06-13. The listed applicant is Teca, Inc.. The 510(k) number is K851232.

When did TECA MONTAGE II receive FDA 510(k) clearance?

TECA MONTAGE II received FDA 510(k) clearance on 1985-06-13, under 510(k) number K851232.

Who is the listed applicant for TECA MONTAGE II?

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

What is the FDA product code for TECA MONTAGE II?

The FDA product code for TECA MONTAGE II is GWQ.

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Other records listing Teca, Inc. as applicant

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Related Devices (Code: GWQ)

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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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