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FDA 510(k)

CARDIO-SCOPE MINI MONITOR

K-Number: K831878 · 1983-09-29

ApplicantW.E. Leder Enterprises, Inc.
Decision Date1983-09-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-SCOPE MINI MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is W.E. Leder Enterprises, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K831878. 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 CARDIO-SCOPE MINI MONITOR?

CARDIO-SCOPE MINI MONITOR is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is W.E. Leder Enterprises, Inc.. The 510(k) number is K831878.

When did CARDIO-SCOPE MINI MONITOR receive FDA 510(k) clearance?

CARDIO-SCOPE MINI MONITOR received FDA 510(k) clearance on 1983-09-29, under 510(k) number K831878.

Who is the listed applicant for CARDIO-SCOPE MINI MONITOR?

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

What is the FDA product code for CARDIO-SCOPE MINI MONITOR?

The FDA product code for CARDIO-SCOPE MINI MONITOR is DPS.

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Other records listing W.E. Leder Enterprises, 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.

K831877ARF 850 EK831981LARYNGESCOPEK830161ANESTHESIA APATATUS #D-25K830160ANESTHESIA APPARATUS #FO 20SK830159ANESTHESIA APPARATUS PH-35

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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