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FDA 510(k)

ORBITOME-UG

K-Number: K780319 · 1978-03-14

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1978-03-14
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORBITOME-UG 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 1978-03-14 under 510(k) number K780319. 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 ORBITOME-UG?

ORBITOME-UG is a medical device that received FDA 510(k) clearance on 1978-03-14. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K780319.

When did ORBITOME-UG receive FDA 510(k) clearance?

ORBITOME-UG received FDA 510(k) clearance on 1978-03-14, under 510(k) number K780319.

Who is the listed applicant for ORBITOME-UG?

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 ORBITOME-UG?

The FDA product code for ORBITOME-UG is IZF.

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Related Devices (Code: IZF)

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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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