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FDA 510(k)

CEROX

K-Number: K131854 · 2013-09-13

ApplicantOr-Nim Medical , Ltd.
Decision Date2013-09-13
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CEROX 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 2013-09-13 under 510(k) number K131854. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEROX?

CEROX is a medical device that received FDA 510(k) clearance on 2013-09-13. The listed applicant is Or-Nim Medical , Ltd.. The 510(k) number is K131854.

When did CEROX receive FDA 510(k) clearance?

CEROX received FDA 510(k) clearance on 2013-09-13, under 510(k) number K131854.

Who is the listed applicant for CEROX?

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?

The FDA product code for CEROX is DPW.

Related Clinical Trials

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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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.

K100875CEROX, MODEL 321OFK093923CEROX MODEL 3210K073407PACIFICA

Related Devices (Code: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, 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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