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)

NI-PACER 1

K-Number: K854853 · 1986-02-14

ApplicantAssociated Medical Devices, Inc.
Decision Date1986-02-14
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NI-PACER 1 is the device name listed in this FDA 510(k) record. The listed applicant is Associated Medical Devices, Inc.. It received FDA 510(k) clearance on 1986-02-14 under 510(k) number K854853. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NI-PACER 1?

NI-PACER 1 is a medical device that received FDA 510(k) clearance on 1986-02-14. The listed applicant is Associated Medical Devices, Inc.. The 510(k) number is K854853.

When did NI-PACER 1 receive FDA 510(k) clearance?

NI-PACER 1 received FDA 510(k) clearance on 1986-02-14, under 510(k) number K854853.

Who is the listed applicant for NI-PACER 1?

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

What is the FDA product code for NI-PACER 1?

The FDA product code for NI-PACER 1 is DRO.

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 Associated Medical Devices, 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.

K821095SPHYGURITE

Related Devices (Code: DRO)

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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, 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.

↑