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FDA 510(k)

MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION

K-Number: K862748 · 1986-08-25

ApplicantCambridge Medical Instruments, Inc.
Decision Date1986-08-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Medical Instruments, Inc.. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K862748. 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 MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION?

MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Cambridge Medical Instruments, Inc.. The 510(k) number is K862748.

When did MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION receive FDA 510(k) clearance?

MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION received FDA 510(k) clearance on 1986-08-25, under 510(k) number K862748.

Who is the listed applicant for MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION?

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

What is the FDA product code for MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION?

The FDA product code for MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION is DPS.

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Other records listing Cambridge Medical Instruments, 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.

K896772EKG, ECG KENZ, ECG 303K896771EKG, ECG KENZ, ECG 302K895961MODEL MC6500 ELECTROCARDIOGRAPHK883454MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPHK871993MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPHK854282PREVIEW XT

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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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