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FDA 510(k)

MEDAC SYSTEM/3

K-Number: K914925 · 1993-10-21

ApplicantDavicon, Inc.
Decision Date1993-10-21
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDAC SYSTEM/3 is the device name listed in this FDA 510(k) record. The listed applicant is Davicon, Inc.. It received FDA 510(k) clearance on 1993-10-21 under 510(k) number K914925. 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 MEDAC SYSTEM/3?

MEDAC SYSTEM/3 is a medical device that received FDA 510(k) clearance on 1993-10-21. The listed applicant is Davicon, Inc.. The 510(k) number is K914925.

When did MEDAC SYSTEM/3 receive FDA 510(k) clearance?

MEDAC SYSTEM/3 received FDA 510(k) clearance on 1993-10-21, under 510(k) number K914925.

Who is the listed applicant for MEDAC SYSTEM/3?

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

What is the FDA product code for MEDAC SYSTEM/3?

The FDA product code for MEDAC SYSTEM/3 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 Davicon, 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.

K914920BIOFEEDBACK SYSTEM/3

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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