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)

SYNERGY IOM SYSTEM

K-Number: K984052 · 1999-05-17

ApplicantOxford Instruments Medical Systems
Decision Date1999-05-17
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SYNERGY IOM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Instruments Medical Systems. It received FDA 510(k) clearance on 1999-05-17 under 510(k) number K984052. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERGY IOM SYSTEM?

SYNERGY IOM SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-17. The listed applicant is Oxford Instruments Medical Systems. The 510(k) number is K984052.

When did SYNERGY IOM SYSTEM receive FDA 510(k) clearance?

SYNERGY IOM SYSTEM received FDA 510(k) clearance on 1999-05-17, under 510(k) number K984052.

Who is the listed applicant for SYNERGY IOM SYSTEM?

The FDA 510(k) record lists Oxford Instruments Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNERGY IOM SYSTEM?

The FDA product code for SYNERGY IOM SYSTEM is IKN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Oxford Instruments Medical Systems 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.

K992607SONICAID SYSTEM 8002K970902MEDILOG FD4K961638MEDILOG MPA-SK943862SONICAID MODEL MR-63 AMBULATORY ECG RECORDER

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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.

↑