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FDA 510(k)

ELECTRODE GEL

K-Number: K884504 · 1989-03-09

ApplicantHerbert Stanley Co.
Decision Date1989-03-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRODE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Herbert Stanley Co.. It received FDA 510(k) clearance on 1989-03-09 under 510(k) number K884504. 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 ELECTRODE GEL?

ELECTRODE GEL is a medical device that received FDA 510(k) clearance on 1989-03-09. The listed applicant is Herbert Stanley Co.. The 510(k) number is K884504.

When did ELECTRODE GEL receive FDA 510(k) clearance?

ELECTRODE GEL received FDA 510(k) clearance on 1989-03-09, under 510(k) number K884504.

Who is the listed applicant for ELECTRODE GEL?

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

What is the FDA product code for ELECTRODE GEL?

The FDA product code for ELECTRODE GEL 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 Herbert Stanley Co. 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.

K884503ULTRASONIC TRANSMISSION GEL

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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