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FDA 510(k)

TERATECH MODEL 10V5 SMART PROBE

K-Number: K040840 · 2004-04-14

Decision Date2004-04-14
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TERATECH MODEL 10V5 SMART PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corp.. It received FDA 510(k) clearance on 2004-04-14 under 510(k) number K040840. 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 10V5 SMART PROBE?

TERATECH MODEL 10V5 SMART PROBE is a medical device that received FDA 510(k) clearance on 2004-04-14. The listed applicant is Teratech Corp.. The 510(k) number is K040840.

When did TERATECH MODEL 10V5 SMART PROBE receive FDA 510(k) clearance?

TERATECH MODEL 10V5 SMART PROBE received FDA 510(k) clearance on 2004-04-14, under 510(k) number K040840.

Who is the listed applicant for TERATECH MODEL 10V5 SMART PROBE?

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 10V5 SMART PROBE?

The FDA product code for TERATECH MODEL 10V5 SMART PROBE is ITX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Teratech Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 12 devices →

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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