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FDA 510(k)

TOMAX ULTRASCAN

K-Number: K892653 · 1989-08-28

ApplicantIncubation Industries, Inc.
Decision Date1989-08-28
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOMAX ULTRASCAN is the device name listed in this FDA 510(k) record. The listed applicant is Incubation Industries, Inc.. It received FDA 510(k) clearance on 1989-08-28 under 510(k) number K892653. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMAX ULTRASCAN?

TOMAX ULTRASCAN is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Incubation Industries, Inc.. The 510(k) number is K892653.

When did TOMAX ULTRASCAN receive FDA 510(k) clearance?

TOMAX ULTRASCAN received FDA 510(k) clearance on 1989-08-28, under 510(k) number K892653.

Who is the listed applicant for TOMAX ULTRASCAN?

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

What is the FDA product code for TOMAX ULTRASCAN?

The FDA product code for TOMAX ULTRASCAN is IZF.

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Related Devices (Code: IZF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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