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FDA 510(k)

ZEE ELECTRODE-GEL

K-Number: K812284 · 1981-09-08

ApplicantZee Medical Products Co., Inc.
Decision Date1981-09-08
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ZEE ELECTRODE-GEL is the device name listed in this FDA 510(k) record. The listed applicant is Zee Medical Products Co., Inc.. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812284. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEE ELECTRODE-GEL?

ZEE ELECTRODE-GEL is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Zee Medical Products Co., Inc.. The 510(k) number is K812284.

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

ZEE ELECTRODE-GEL received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812284.

Who is the listed applicant for ZEE ELECTRODE-GEL?

The FDA 510(k) record lists Zee Medical Products Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZEE ELECTRODE-GEL?

The FDA product code for ZEE ELECTRODE-GEL is GYB.

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Other records listing Zee Medical Products Co., 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.

K823501ZEE SPHYGMOMANOMETERK813156ULTRA-WIDE SAFETY SPECTACLE FRAMEK813016ZEE TRACTION SPLINTK812814ZEE SURGICAL INSTRUMENTSK812564ZEE LIFE SUPPORT AIR PANTSK812342ZEE EXTRICATION DEVICE

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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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