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FDA 510(k)

GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF

K-Number: K992152 · 1999-08-17

ApplicantCIVCO Medical Instruments Co., Inc.
Decision Date1999-08-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF 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 1999-08-17 under 510(k) number K992152. 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 TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF?

GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF is a medical device that received FDA 510(k) clearance on 1999-08-17. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K992152.

When did GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF receive FDA 510(k) clearance?

GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF received FDA 510(k) clearance on 1999-08-17, under 510(k) number K992152.

Who is the listed applicant for GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF?

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 TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF?

The FDA product code for GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF is 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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