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FDA 510(k)

CATEGORY 6 OPTHALMIC DEVICES

K-Number: K840310 · 1984-03-16

ApplicantImm Enterprises , Ltd.
Decision Date1984-03-16
Product CodeHOB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CATEGORY 6 OPTHALMIC DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Imm Enterprises , Ltd.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840310. The device is classified under product code HOB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATEGORY 6 OPTHALMIC DEVICES?

CATEGORY 6 OPTHALMIC DEVICES is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K840310.

When did CATEGORY 6 OPTHALMIC DEVICES receive FDA 510(k) clearance?

CATEGORY 6 OPTHALMIC DEVICES received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840310.

Who is the listed applicant for CATEGORY 6 OPTHALMIC DEVICES?

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

What is the FDA product code for CATEGORY 6 OPTHALMIC DEVICES?

The FDA product code for CATEGORY 6 OPTHALMIC DEVICES is HOB.

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Other records listing Imm Enterprises , Ltd. 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.

K840311CAT. 7-EAR, NOSE & THROAT DEVICESK841386KOLLMANN URETHRAL DILATORK841387WESTON RECTAL SNAREK840304CATEGORY 17-MICROBIOLOGY DEVICESK840318CAT. 14-CLINICAL TOXIOLOGY DEVICESK840305CATEGORY 1 CIRCULATORY SYSTEM DEVICE

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Related Devices (Code: HOB)

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.

K840101EYE SURGERY INSTRUMENTTruline Instruments, Inc.K780851CHARLES ENDOCOAGULATOR ACCESSORY FOR ARCVarian Assoc., 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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