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FDA 510(k)

CEROX, MODEL 321OF

K-Number: K100875 · 2011-01-25

ApplicantOr-Nim Medical , Ltd.
Decision Date2011-01-25
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CEROX, MODEL 321OF is the device name listed in this FDA 510(k) record. The listed applicant is Or-Nim Medical , Ltd.. It received FDA 510(k) clearance on 2011-01-25 under 510(k) number K100875. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEROX, MODEL 321OF?

CEROX, MODEL 321OF is a medical device that received FDA 510(k) clearance on 2011-01-25. The listed applicant is Or-Nim Medical , Ltd.. The 510(k) number is K100875.

When did CEROX, MODEL 321OF receive FDA 510(k) clearance?

CEROX, MODEL 321OF received FDA 510(k) clearance on 2011-01-25, under 510(k) number K100875.

Who is the listed applicant for CEROX, MODEL 321OF?

The FDA 510(k) record lists Or-Nim Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEROX, MODEL 321OF?

The FDA product code for CEROX, MODEL 321OF is MUD.

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Other records listing Or-Nim Medical , Ltd. 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.

K131854CEROXK093923CEROX MODEL 3210K073407PACIFICA

Related Devices (Code: MUD)

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.

K254129Spectrum-2Neko Health ABK243324Masimo O3 Regional OximeterMasimo CorporationK250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards LifesciencesK241393ODI-TechOdi Medical ASK240601SnapshotNIR model KD205Kent Imaging, Inc.

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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