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FDA 510(k)

BITEM LOCK, MODELS SW006, SW012

K-Number: K994357 · 2000-03-14

ApplicantThermoelastic Technologies, Inc.
Decision Date2000-03-14
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BITEM LOCK, MODELS SW006, SW012 is the device name listed in this FDA 510(k) record. The listed applicant is Thermoelastic Technologies, Inc.. It received FDA 510(k) clearance on 2000-03-14 under 510(k) number K994357. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BITEM LOCK, MODELS SW006, SW012?

BITEM LOCK, MODELS SW006, SW012 is a medical device that received FDA 510(k) clearance on 2000-03-14. The listed applicant is Thermoelastic Technologies, Inc.. The 510(k) number is K994357.

When did BITEM LOCK, MODELS SW006, SW012 receive FDA 510(k) clearance?

BITEM LOCK, MODELS SW006, SW012 received FDA 510(k) clearance on 2000-03-14, under 510(k) number K994357.

Who is the listed applicant for BITEM LOCK, MODELS SW006, SW012?

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

What is the FDA product code for BITEM LOCK, MODELS SW006, SW012?

The FDA product code for BITEM LOCK, MODELS SW006, SW012 is EJF.

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Other records listing Thermoelastic Technologies, Inc. as applicant

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Related Devices (Code: EJF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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