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FDA 510(k)

PARAGON 420, CARDIAC MONITOR

K-Number: K861067 · 1986-06-05

ApplicantLife Sensing Instrument Company, Inc.
Decision Date1986-06-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PARAGON 420, CARDIAC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Life Sensing Instrument Company, Inc.. It received FDA 510(k) clearance on 1986-06-05 under 510(k) number K861067. 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 PARAGON 420, CARDIAC MONITOR?

PARAGON 420, CARDIAC MONITOR is a medical device that received FDA 510(k) clearance on 1986-06-05. The listed applicant is Life Sensing Instrument Company, Inc.. The 510(k) number is K861067.

When did PARAGON 420, CARDIAC MONITOR receive FDA 510(k) clearance?

PARAGON 420, CARDIAC MONITOR received FDA 510(k) clearance on 1986-06-05, under 510(k) number K861067.

Who is the listed applicant for PARAGON 420, CARDIAC MONITOR?

The FDA 510(k) record lists Life Sensing Instrument Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAGON 420, CARDIAC MONITOR?

The FDA product code for PARAGON 420, CARDIAC MONITOR is DPS.

Related Clinical Trials

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Other records listing Life Sensing Instrument Company, 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.

K960884TELE TRENS TM 10K931136APOLLO CAMERAK896967HTS 820 CARDIAC MONITORK884524HTS 220 CARDIAC MONITOR

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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