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FDA 510(k)

CARDISUNY 501BIII

K-Number: K901948 · 1990-07-17

ApplicantGraham-Field, Inc.
Decision Date1990-07-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDISUNY 501BIII is the device name listed in this FDA 510(k) record. The listed applicant is Graham-Field, Inc.. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K901948. 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 CARDISUNY 501BIII?

CARDISUNY 501BIII is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Graham-Field, Inc.. The 510(k) number is K901948.

When did CARDISUNY 501BIII receive FDA 510(k) clearance?

CARDISUNY 501BIII received FDA 510(k) clearance on 1990-07-17, under 510(k) number K901948.

Who is the listed applicant for CARDISUNY 501BIII?

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

What is the FDA product code for CARDISUNY 501BIII?

The FDA product code for CARDISUNY 501BIII is DPS.

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Other records listing Graham-Field, 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.

K970035JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009K961857LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060K924876TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIEDK904904MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATIONK901947CARDISUNY 501ABK900849CARDISUNY, 501BX

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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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