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FDA 510(k)

TECA/MEDELEC MISTRAL

K-Number: K880593 · 1988-04-06

ApplicantTeca, Inc.
Decision Date1988-04-06
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA/MEDELEC MISTRAL is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1988-04-06 under 510(k) number K880593. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA/MEDELEC MISTRAL?

TECA/MEDELEC MISTRAL is a medical device that received FDA 510(k) clearance on 1988-04-06. The listed applicant is Teca, Inc.. The 510(k) number is K880593.

When did TECA/MEDELEC MISTRAL receive FDA 510(k) clearance?

TECA/MEDELEC MISTRAL received FDA 510(k) clearance on 1988-04-06, under 510(k) number K880593.

Who is the listed applicant for TECA/MEDELEC MISTRAL?

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/MEDELEC MISTRAL?

The FDA product code for TECA/MEDELEC MISTRAL is GWE.

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Other records listing Teca, Inc. as applicant

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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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