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FDA 510(k)

RARE EARTH INTRA-OCULAR MAGNET

K-Number: K860960 · 1986-03-31

ApplicantAmeritek, Inc.
Decision Date1986-03-31
Product CodeHPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RARE EARTH INTRA-OCULAR MAGNET is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek, Inc.. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K860960. The device is classified under product code HPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RARE EARTH INTRA-OCULAR MAGNET?

RARE EARTH INTRA-OCULAR MAGNET is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Ameritek, Inc.. The 510(k) number is K860960.

When did RARE EARTH INTRA-OCULAR MAGNET receive FDA 510(k) clearance?

RARE EARTH INTRA-OCULAR MAGNET received FDA 510(k) clearance on 1986-03-31, under 510(k) number K860960.

Who is the listed applicant for RARE EARTH INTRA-OCULAR MAGNET?

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

What is the FDA product code for RARE EARTH INTRA-OCULAR MAGNET?

The FDA product code for RARE EARTH INTRA-OCULAR MAGNET is HPN.

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Related Devices (Code: HPN)

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.

K905237EYE SEE INSTRUMENTKing Tool, Inc.K896473H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUREmory University School of MedicineK880855PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAGRichard James, Inc.K831702RARE-EARTH INTRA-OCULAR MAGNETMiami Eye Technology, Inc.

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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