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FDA 510(k)

5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM

K-Number: K860009 · 1986-08-20

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1986-08-20
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM 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 1986-08-20 under 510(k) number K860009. 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 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM?

5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-20. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K860009.

When did 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1986-08-20, under 510(k) number K860009.

Who is the listed applicant for 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM?

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 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM?

The FDA product code for 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM 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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