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FDA 510(k)

OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275

K-Number: K030737 · 2003-10-10

ApplicantCtf Systems (2001), Inc.
Decision Date2003-10-10
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 is the device name listed in this FDA 510(k) record. The listed applicant is Ctf Systems (2001), Inc.. It received FDA 510(k) clearance on 2003-10-10 under 510(k) number K030737. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275?

OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 is a medical device that received FDA 510(k) clearance on 2003-10-10. The listed applicant is Ctf Systems (2001), Inc.. The 510(k) number is K030737.

When did OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 receive FDA 510(k) clearance?

OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 received FDA 510(k) clearance on 2003-10-10, under 510(k) number K030737.

Who is the listed applicant for OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275?

The FDA 510(k) record lists Ctf Systems (2001), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275?

The FDA product code for OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 is OLX.

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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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