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FDA 510(k)

MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701

K-Number: K043354 · 2005-01-10

Decision Date2005-01-10
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Research, Inc.. It received FDA 510(k) clearance on 2005-01-10 under 510(k) number K043354. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701?

MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 is a medical device that received FDA 510(k) clearance on 2005-01-10. The listed applicant is Invivo Research, Inc.. The 510(k) number is K043354.

When did MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 receive FDA 510(k) clearance?

MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 received FDA 510(k) clearance on 2005-01-10, under 510(k) number K043354.

Who is the listed applicant for MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701?

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

What is the FDA product code for MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701?

The FDA product code for MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 is DRT.

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 Invivo Research, Inc. 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.

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Related Devices (Code: DRT)

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

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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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