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FDA 510(k)

MINI PECG-MODIFICATION

K-Number: K841148 · 1984-04-17

ApplicantIntersect Systems, Inc.
Decision Date1984-04-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINI PECG-MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1984-04-17 under 510(k) number K841148. 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 MINI PECG-MODIFICATION?

MINI PECG-MODIFICATION is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K841148.

When did MINI PECG-MODIFICATION receive FDA 510(k) clearance?

MINI PECG-MODIFICATION received FDA 510(k) clearance on 1984-04-17, under 510(k) number K841148.

Who is the listed applicant for MINI PECG-MODIFICATION?

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

What is the FDA product code for MINI PECG-MODIFICATION?

The FDA product code for MINI PECG-MODIFICATION is DPS.

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Other records listing Intersect Systems, 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.

K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENT

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Related Devices (Code: DPS)

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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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