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FDA 510(k)

OMNIPRO INCLINE

K-Number: K092018 · 2009-09-18

ApplicantIba Dosimetry GmbH
Decision Date2009-09-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNIPRO INCLINE is the device name listed in this FDA 510(k) record. The listed applicant is Iba Dosimetry GmbH. It received FDA 510(k) clearance on 2009-09-18 under 510(k) number K092018. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIPRO INCLINE?

OMNIPRO INCLINE is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is Iba Dosimetry GmbH. The 510(k) number is K092018.

When did OMNIPRO INCLINE receive FDA 510(k) clearance?

OMNIPRO INCLINE received FDA 510(k) clearance on 2009-09-18, under 510(k) number K092018.

Who is the listed applicant for OMNIPRO INCLINE?

The FDA 510(k) record lists Iba Dosimetry GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIPRO INCLINE?

The FDA product code for OMNIPRO INCLINE is IYE.

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Other records listing Iba Dosimetry GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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