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)

SAVI WIRELESS, MODEL PM500

K-Number: K091696 · 2009-10-26

ApplicantMedicomp, Inc.
Decision Date2009-10-26
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAVI WIRELESS, MODEL PM500 is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 2009-10-26 under 510(k) number K091696. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAVI WIRELESS, MODEL PM500?

SAVI WIRELESS, MODEL PM500 is a medical device that received FDA 510(k) clearance on 2009-10-26. The listed applicant is Medicomp, Inc.. The 510(k) number is K091696.

When did SAVI WIRELESS, MODEL PM500 receive FDA 510(k) clearance?

SAVI WIRELESS, MODEL PM500 received FDA 510(k) clearance on 2009-10-26, under 510(k) number K091696.

Who is the listed applicant for SAVI WIRELESS, MODEL PM500?

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

What is the FDA product code for SAVI WIRELESS, MODEL PM500?

The FDA product code for SAVI WIRELESS, MODEL PM500 is DRG.

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 Medicomp, 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.

K173170Epicardia AnywhereK161916TelePatch Cardiac MonitorK090834EPICARDIA 5000K043454CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410K981119CARDIOPAL MODEL NUMBER PM20K952846EPICARDIA

View all 23 devices →

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, 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.

↑