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FDA 510(k)

CEROX MODEL 3210

K-Number: K093923 · 2010-01-19

ApplicantOr-Nim Medical , Ltd.
Decision Date2010-01-19
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CEROX MODEL 3210 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 2010-01-19 under 510(k) number K093923. 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 3210?

CEROX MODEL 3210 is a medical device that received FDA 510(k) clearance on 2010-01-19. The listed applicant is Or-Nim Medical , Ltd.. The 510(k) number is K093923.

When did CEROX MODEL 3210 receive FDA 510(k) clearance?

CEROX MODEL 3210 received FDA 510(k) clearance on 2010-01-19, under 510(k) number K093923.

Who is the listed applicant for CEROX MODEL 3210?

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 3210?

The FDA product code for CEROX MODEL 3210 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.

K131854CEROXK100875CEROX, MODEL 321OFK073407PACIFICA

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

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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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