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FDA 510(k)

VALLEYLAB PROCISION(TM) SYSTEM

K-Number: K945688 · 1995-06-13

ApplicantValleylab, Inc.
Decision Date1995-06-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VALLEYLAB PROCISION(TM) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1995-06-13 under 510(k) number K945688. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALLEYLAB PROCISION(TM) SYSTEM?

VALLEYLAB PROCISION(TM) SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-13. The listed applicant is Valleylab, Inc.. The 510(k) number is K945688.

When did VALLEYLAB PROCISION(TM) SYSTEM receive FDA 510(k) clearance?

VALLEYLAB PROCISION(TM) SYSTEM received FDA 510(k) clearance on 1995-06-13, under 510(k) number K945688.

Who is the listed applicant for VALLEYLAB PROCISION(TM) SYSTEM?

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

What is the FDA product code for VALLEYLAB PROCISION(TM) SYSTEM?

The FDA product code for VALLEYLAB PROCISION(TM) SYSTEM is GEI.

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Other records listing Valleylab, 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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