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FDA 510(k)

COSMED K4

K-Number: K963373 · 1997-09-10

ApplicantCosmed Srl
Decision Date1997-09-10
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COSMED K4 is the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 1997-09-10 under 510(k) number K963373. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMED K4?

COSMED K4 is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Cosmed Srl. The 510(k) number is K963373.

When did COSMED K4 receive FDA 510(k) clearance?

COSMED K4 received FDA 510(k) clearance on 1997-09-10, under 510(k) number K963373.

Who is the listed applicant for COSMED K4?

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

What is the FDA product code for COSMED K4?

The FDA product code for COSMED K4 is BZC.

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 Cosmed Srl 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.

K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsK162515COSMED K5 Wearable Metabolic TechnologyK120146QUARK SERIESK093174SPIROPALMK071533FITMATE SERIESK040549COSMED PONY FX

View all 10 devices →

Related Devices (Code: BZC)

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.

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire MedicalK190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K162515COSMED K5 Wearable Metabolic TechnologyCosmed SrlK161295MiniBox +Pulmone Advanced Medical Devices, 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.

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