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FDA 510(k)

HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER

K-Number: K950004 · 1995-10-24

ApplicantAerotel, Ltd.
Decision Date1995-10-24
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Aerotel, Ltd.. It received FDA 510(k) clearance on 1995-10-24 under 510(k) number K950004. 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 HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER?

HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER is a medical device that received FDA 510(k) clearance on 1995-10-24. The listed applicant is Aerotel, Ltd.. The 510(k) number is K950004.

When did HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER receive FDA 510(k) clearance?

HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER received FDA 510(k) clearance on 1995-10-24, under 510(k) number K950004.

Who is the listed applicant for HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER?

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

What is the FDA product code for HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER?

The FDA product code for HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER 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 Aerotel, Ltd. 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.

K980144HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTERK953762HEART 400 ECG TRANSMITTERK961362AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACEK931020HEART 1001K930314HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE

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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