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FDA 510(k)

BINOCULAR LOUPE

K-Number: K830878 · 1983-04-06

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

Device Summary

BINOCULAR LOUPE 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 K830878. The device is classified under product code HJH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINOCULAR LOUPE?

BINOCULAR LOUPE 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 K830878.

When did BINOCULAR LOUPE receive FDA 510(k) clearance?

BINOCULAR LOUPE received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830878.

Who is the listed applicant for BINOCULAR LOUPE?

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 LOUPE?

The FDA product code for BINOCULAR LOUPE is HJH.

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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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Related Devices (Code: HJH)

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.

K874845MALIS SURGICAL LOUPESValley Forge Scientific Corp.K863983EXETER OPERATING LOUPEExeter Instruments, 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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