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FDA 510(k)

AML (ANGLE MAGNIFYING LENS

K-Number: K823719 · 1983-01-05

ApplicantNikon, Inc.
Decision Date1983-01-05
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AML (ANGLE MAGNIFYING LENS is the device name listed in this FDA 510(k) record. The listed applicant is Nikon, Inc.. It received FDA 510(k) clearance on 1983-01-05 under 510(k) number K823719. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AML (ANGLE MAGNIFYING LENS?

AML (ANGLE MAGNIFYING LENS is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is Nikon, Inc.. The 510(k) number is K823719.

When did AML (ANGLE MAGNIFYING LENS receive FDA 510(k) clearance?

AML (ANGLE MAGNIFYING LENS received FDA 510(k) clearance on 1983-01-05, under 510(k) number K823719.

Who is the listed applicant for AML (ANGLE MAGNIFYING LENS?

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

What is the FDA product code for AML (ANGLE MAGNIFYING LENS?

The FDA product code for AML (ANGLE MAGNIFYING LENS is HKI.

Related Clinical Trials

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Other records listing Nikon, 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.

K851508NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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