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FDA 510(k)

THE BAGNOLI-2 EMG SYSTEM

K-Number: K945286 · 1995-09-15

ApplicantDelsys, Inc.
Decision Date1995-09-15
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE BAGNOLI-2 EMG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Delsys, Inc.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K945286. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BAGNOLI-2 EMG SYSTEM?

THE BAGNOLI-2 EMG SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Delsys, Inc.. The 510(k) number is K945286.

When did THE BAGNOLI-2 EMG SYSTEM receive FDA 510(k) clearance?

THE BAGNOLI-2 EMG SYSTEM received FDA 510(k) clearance on 1995-09-15, under 510(k) number K945286.

Who is the listed applicant for THE BAGNOLI-2 EMG SYSTEM?

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

What is the FDA product code for THE BAGNOLI-2 EMG SYSTEM?

The FDA product code for THE BAGNOLI-2 EMG SYSTEM is HCC.

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.

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Other records listing Delsys, Inc. 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.

K990356THE BAGNOLI-8 EMG SYSTEMK981934THE BAGNOLI-4 EMG SYSTEM

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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