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FDA 510(k)

ISO-MAMMO

K-Number: K860129 · 1986-03-06

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1986-03-06
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISO-MAMMO is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1986-03-06 under 510(k) number K860129. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISO-MAMMO?

ISO-MAMMO is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K860129.

When did ISO-MAMMO receive FDA 510(k) clearance?

ISO-MAMMO received FDA 510(k) clearance on 1986-03-06, under 510(k) number K860129.

Who is the listed applicant for ISO-MAMMO?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISO-MAMMO?

The FDA product code for ISO-MAMMO is IZH.

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Related Devices (Code: IZH)

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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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