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FDA 510(k)

WIM-PC, MODEL 1010

K-Number: K071955 · 2007-11-01

ApplicantKarmelsonix
Decision Date2007-11-01
Product CodeBZM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WIM-PC, MODEL 1010 is the device name listed in this FDA 510(k) record. The listed applicant is Karmelsonix. It received FDA 510(k) clearance on 2007-11-01 under 510(k) number K071955. The device is classified under product code BZM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIM-PC, MODEL 1010?

WIM-PC, MODEL 1010 is a medical device that received FDA 510(k) clearance on 2007-11-01. The listed applicant is Karmelsonix. The 510(k) number is K071955.

When did WIM-PC, MODEL 1010 receive FDA 510(k) clearance?

WIM-PC, MODEL 1010 received FDA 510(k) clearance on 2007-11-01, under 510(k) number K071955.

Who is the listed applicant for WIM-PC, MODEL 1010?

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 WIM-PC, MODEL 1010?

The FDA product code for WIM-PC, MODEL 1010 is BZM.

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 SYSTEMK101022PULMOTRACK 5050 WHOLTER, MODEL 5050K090863PERSONAL WHEEZOMETER

Related Devices (Code: BZM)

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 SYSTEMKarmelsonixK090863PERSONAL WHEEZOMETERKarmelsonixK012387STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEMStethographics, Inc.K980878PULMOTRACK,MODEL 1010Karmel Medical Acoustic Technologies , Ltd.K974200ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMOrca Diagnostics Corp.K955432CPX, CCM, CATH WITH 15% CO2Medical Graphics Corp.

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.

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