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FDA 510(k)

MINISCOPE MS-2B ELECTROCARDIOSCOPE

K-Number: K791421 · 1979-08-28

ApplicantRenesco International, Inc.
Decision Date1979-08-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINISCOPE MS-2B ELECTROCARDIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Renesco International, Inc.. It received FDA 510(k) clearance on 1979-08-28 under 510(k) number K791421. 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 MINISCOPE MS-2B ELECTROCARDIOSCOPE?

MINISCOPE MS-2B ELECTROCARDIOSCOPE is a medical device that received FDA 510(k) clearance on 1979-08-28. The listed applicant is Renesco International, Inc.. The 510(k) number is K791421.

When did MINISCOPE MS-2B ELECTROCARDIOSCOPE receive FDA 510(k) clearance?

MINISCOPE MS-2B ELECTROCARDIOSCOPE received FDA 510(k) clearance on 1979-08-28, under 510(k) number K791421.

Who is the listed applicant for MINISCOPE MS-2B ELECTROCARDIOSCOPE?

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

What is the FDA product code for MINISCOPE MS-2B ELECTROCARDIOSCOPE?

The FDA product code for MINISCOPE MS-2B ELECTROCARDIOSCOPE is DPS.

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 Renesco International, 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.

K800659SCHILLER MSG-1K791422MINISPIROMETER SP-1K791420MINIGRAPH MG-I ELECTROCARDIOGRAPH

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

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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