Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EBW NM 2.0

K-Number: K111336 · 2011-05-24

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2011-05-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EBW NM 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2011-05-24 under 510(k) number K111336. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBW NM 2.0?

EBW NM 2.0 is a medical device that received FDA 510(k) clearance on 2011-05-24. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K111336.

When did EBW NM 2.0 receive FDA 510(k) clearance?

EBW NM 2.0 received FDA 510(k) clearance on 2011-05-24, under 510(k) number K111336.

Who is the listed applicant for EBW NM 2.0?

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

What is the FDA product code for EBW NM 2.0?

The FDA product code for EBW NM 2.0 is LLZ.

Other records listing Philips Medical Systems (Cleveland), Inc. 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.

K171850Philips CT Big BoreK172406Ingenuity TFK162838Philips iCT CT SystemK163711IQon Spectral CTK170086Pinnacle Radiation Therapy Planning SystemK160743Philips Ingenuity CT

View all 190 devices →

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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.

↑