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FDA 510(k)

COMP-ACT IV

K-Number: K791795 · 1979-09-27

ApplicantMedcraft Corp.
Decision Date1979-09-27
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMP-ACT IV is the device name listed in this FDA 510(k) record. The listed applicant is Medcraft Corp.. It received FDA 510(k) clearance on 1979-09-27 under 510(k) number K791795. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMP-ACT IV?

COMP-ACT IV is a medical device that received FDA 510(k) clearance on 1979-09-27. The listed applicant is Medcraft Corp.. The 510(k) number is K791795.

When did COMP-ACT IV receive FDA 510(k) clearance?

COMP-ACT IV received FDA 510(k) clearance on 1979-09-27, under 510(k) number K791795.

Who is the listed applicant for COMP-ACT IV?

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

What is the FDA product code for COMP-ACT IV?

The FDA product code for COMP-ACT IV is DPS.

Other records listing Medcraft Corp. 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.

K860467ELECTROSHOCK UNIT NEUROLOGY MODEL B-25K760510MONITORING SYSTEM, REHABILITATIONK760509TREADMILL, DIAGNOSTICK760508ACCUTAPE 24

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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