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FDA 510(k)

APPLISCOPE

K-Number: K864978 · 1987-02-19

ApplicantGrandcor Medical Systems
Decision Date1987-02-19
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APPLISCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Grandcor Medical Systems. It received FDA 510(k) clearance on 1987-02-19 under 510(k) number K864978. 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 APPLISCOPE?

APPLISCOPE is a medical device that received FDA 510(k) clearance on 1987-02-19. The listed applicant is Grandcor Medical Systems. The 510(k) number is K864978.

When did APPLISCOPE receive FDA 510(k) clearance?

APPLISCOPE received FDA 510(k) clearance on 1987-02-19, under 510(k) number K864978.

Who is the listed applicant for APPLISCOPE?

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

What is the FDA product code for APPLISCOPE?

The FDA product code for APPLISCOPE 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 Grandcor Medical Systems 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.

K905480SPIROSCOPEK895547GRANDCOR/CARDIOLINE ECT STRESS TESTINGK883410CARDIOMEGA-TK871890CARDIO-MEGA SYSTEMK864260APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)K864581APPLIDYN

View all 8 devices →

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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