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)

Ossler Exam Scope

K-Number: K171188 · 2017-06-23

ApplicantLr Med, Inc.
Decision Date2017-06-23
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ossler Exam Scope is the device name listed in this FDA 510(k) record. The listed applicant is Lr Med, Inc.. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K171188. 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 Ossler Exam Scope?

Ossler Exam Scope is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Lr Med, Inc.. The 510(k) number is K171188.

When did Ossler Exam Scope receive FDA 510(k) clearance?

Ossler Exam Scope received FDA 510(k) clearance on 2017-06-23, under 510(k) number K171188.

Who is the listed applicant for Ossler Exam Scope?

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

What is the FDA product code for Ossler Exam Scope?

The FDA product code for Ossler Exam Scope is DRG.

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.

↑