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)

PULMOTRACK 5050 WHOLTER, MODEL 5050

K-Number: K101022 · 2010-07-09

ApplicantKarmelsonix
Decision Date2010-07-09
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULMOTRACK 5050 WHOLTER, MODEL 5050 is the device name listed in this FDA 510(k) record. The listed applicant is Karmelsonix. It received FDA 510(k) clearance on 2010-07-09 under 510(k) number K101022. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULMOTRACK 5050 WHOLTER, MODEL 5050?

PULMOTRACK 5050 WHOLTER, MODEL 5050 is a medical device that received FDA 510(k) clearance on 2010-07-09. The listed applicant is Karmelsonix. The 510(k) number is K101022.

When did PULMOTRACK 5050 WHOLTER, MODEL 5050 receive FDA 510(k) clearance?

PULMOTRACK 5050 WHOLTER, MODEL 5050 received FDA 510(k) clearance on 2010-07-09, under 510(k) number K101022.

Who is the listed applicant for PULMOTRACK 5050 WHOLTER, MODEL 5050?

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

What is the FDA product code for PULMOTRACK 5050 WHOLTER, MODEL 5050?

The FDA product code for PULMOTRACK 5050 WHOLTER, MODEL 5050 is DSH.

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 Karmelsonix 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.

K102229PULMOTRACK 2020 SYSTEMK090863PERSONAL WHEEZOMETERK071955WIM-PC, MODEL 1010

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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.

↑