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FDA 510(k)

GENERAL PURPOSE LATEX TRANSDUCER COVERS

K-Number: K970515 · 1997-06-20

ApplicantCIVCO Medical Instruments Co., Inc.
Decision Date1997-06-20
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENERAL PURPOSE LATEX TRANSDUCER COVERS is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 1997-06-20 under 510(k) number K970515. 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 GENERAL PURPOSE LATEX TRANSDUCER COVERS?

GENERAL PURPOSE LATEX TRANSDUCER COVERS is a medical device that received FDA 510(k) clearance on 1997-06-20. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K970515.

When did GENERAL PURPOSE LATEX TRANSDUCER COVERS receive FDA 510(k) clearance?

GENERAL PURPOSE LATEX TRANSDUCER COVERS received FDA 510(k) clearance on 1997-06-20, under 510(k) number K970515.

Who is the listed applicant for GENERAL PURPOSE LATEX TRANSDUCER COVERS?

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

What is the FDA product code for GENERAL PURPOSE LATEX TRANSDUCER COVERS?

The FDA product code for GENERAL PURPOSE LATEX TRANSDUCER COVERS 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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