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)

REDSENSE ALARM SYSTEM

K-Number: K130554 · 2013-11-22

ApplicantRedsense Medical AB
Decision Date2013-11-22
Product CodeODX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REDSENSE ALARM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Redsense Medical AB. It received FDA 510(k) clearance on 2013-11-22 under 510(k) number K130554. The device is classified under product code ODX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDSENSE ALARM SYSTEM?

REDSENSE ALARM SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-22. The listed applicant is Redsense Medical AB. The 510(k) number is K130554.

When did REDSENSE ALARM SYSTEM receive FDA 510(k) clearance?

REDSENSE ALARM SYSTEM received FDA 510(k) clearance on 2013-11-22, under 510(k) number K130554.

Who is the listed applicant for REDSENSE ALARM SYSTEM?

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

What is the FDA product code for REDSENSE ALARM SYSTEM?

The FDA product code for REDSENSE ALARM SYSTEM is ODX.

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 Redsense Medical AB 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.

K103242REDSENSE-ALARM UNIT AND SENSORK092955REDSENSE-HOME USEK071013REDSENSE

Related Devices (Code: ODX)

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.

K103242REDSENSE-ALARM UNIT AND SENSORRedsense Medical ABK092955REDSENSE-HOME USERedsense Medical ABK071013REDSENSERedsense Medical AB

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.

↑