FDA 510(k)

AL-3300

K-Number: K940997 · 1994-09-29

Decision Date1994-09-29

Product CodeHLM

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

AL-3300 is the device name listed in this FDA 510(k) record. The listed applicant is Hoya Corp. USA. It received FDA 510(k) clearance on 1994-09-29 under 510(k) number K940997. The device is classified under product code HLM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AL-3300?

AL-3300 is a medical device that received FDA 510(k) clearance on 1994-09-29. The listed applicant is Hoya Corp. USA. The 510(k) number is K940997.

When did AL-3300 receive FDA 510(k) clearance?

AL-3300 received FDA 510(k) clearance on 1994-09-29, under 510(k) number K940997.

Who is the listed applicant for AL-3300?

The FDA 510(k) record lists Hoya Corp. USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AL-3300?

The FDA product code for AL-3300 is HLM.

Related Devices (Code: HLM)

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.

K944022LENSCHEKLeica, Inc.K936199AUTOMATIC LENSOMETERCanon USA, Inc.K930441MARCO STANDARD LENSMETERS 101,201Marco Ophthalmic, Inc.K930445MARCO LM-770 DIGITAL PROJECTION LENSMETERMarco Ophthalmic, Inc.K924776BURTON LENSMETER - MODEL 2021R.H. Burton Co.K924785BURTON RADIUSGAUGE - MODEL 2030R.H. Burton Co.

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.