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FDA 510(k)

MODEL SSR1 HOLTER MONITOR

K-Number: K873337 · 1987-10-09

ApplicantCardiodata Corp.
Decision Date1987-10-09
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SSR1 HOLTER MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiodata Corp.. It received FDA 510(k) clearance on 1987-10-09 under 510(k) number K873337. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL SSR1 HOLTER MONITOR?

MODEL SSR1 HOLTER MONITOR is a medical device that received FDA 510(k) clearance on 1987-10-09. The listed applicant is Cardiodata Corp.. The 510(k) number is K873337.

When did MODEL SSR1 HOLTER MONITOR receive FDA 510(k) clearance?

MODEL SSR1 HOLTER MONITOR received FDA 510(k) clearance on 1987-10-09, under 510(k) number K873337.

Who is the listed applicant for MODEL SSR1 HOLTER MONITOR?

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

What is the FDA product code for MODEL SSR1 HOLTER MONITOR?

The FDA product code for MODEL SSR1 HOLTER MONITOR is DSH.

Related Clinical Trials

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Other records listing Cardiodata Corp. as applicant

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K900607MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11K881488HOLTER SCANNERK860167PRODIGY AND PRODIGY PLUS

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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