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FDA 510(k)

BINOCULAR MAGNIFIER 2X

K-Number: K830774 · 1983-04-06

ApplicantAlmore Intl., Inc.
Decision Date1983-04-06
Product CodeHKC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BINOCULAR MAGNIFIER 2X is the device name listed in this FDA 510(k) record. The listed applicant is Almore Intl., Inc.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830774. The device is classified under product code HKC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINOCULAR MAGNIFIER 2X?

BINOCULAR MAGNIFIER 2X is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Almore Intl., Inc.. The 510(k) number is K830774.

When did BINOCULAR MAGNIFIER 2X receive FDA 510(k) clearance?

BINOCULAR MAGNIFIER 2X received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830774.

Who is the listed applicant for BINOCULAR MAGNIFIER 2X?

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

What is the FDA product code for BINOCULAR MAGNIFIER 2X?

The FDA product code for BINOCULAR MAGNIFIER 2X is HKC.

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Other records listing Almore Intl., 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.

K862851ALMORE FACE MASKK854692MONARCH II BLEACHING INSTRUMENTK854696OP II VISIBLE LIGHT CURING SYSTEMK854690DIAMONDS BURS-COMPOSIT FINISHINGK854691DIAMOND BURS-HANDPIECEK854700EZ-ON TUBING CONDITIONER (LUBRICANT)

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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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