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FDA 510(k)

ULTRASOUND TRANSDUCER ASSEMBLY

K-Number: K862211 · 1987-01-02

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1987-01-02
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND TRANSDUCER ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1987-01-02 under 510(k) number K862211. 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 ULTRASOUND TRANSDUCER ASSEMBLY?

ULTRASOUND TRANSDUCER ASSEMBLY is a medical device that received FDA 510(k) clearance on 1987-01-02. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K862211.

When did ULTRASOUND TRANSDUCER ASSEMBLY receive FDA 510(k) clearance?

ULTRASOUND TRANSDUCER ASSEMBLY received FDA 510(k) clearance on 1987-01-02, under 510(k) number K862211.

Who is the listed applicant for ULTRASOUND TRANSDUCER ASSEMBLY?

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

What is the FDA product code for ULTRASOUND TRANSDUCER ASSEMBLY?

The FDA product code for ULTRASOUND TRANSDUCER ASSEMBLY 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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