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FDA 510(k)

TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES

K-Number: K043278 · 2004-12-13

ApplicantTeratech Corp.
Decision Date2004-12-13
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corp.. It received FDA 510(k) clearance on 2004-12-13 under 510(k) number K043278. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES?

TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES is a medical device that received FDA 510(k) clearance on 2004-12-13. The listed applicant is Teratech Corp.. The 510(k) number is K043278.

When did TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES receive FDA 510(k) clearance?

TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES received FDA 510(k) clearance on 2004-12-13, under 510(k) number K043278.

Who is the listed applicant for TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES?

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

What is the FDA product code for TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES?

The FDA product code for TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES is ITX.

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Related Devices (Code: ITX)

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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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