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FDA 510(k)

ALES

K-Number: K823385 · 1983-03-09

ApplicantOms
Decision Date1983-03-09
Product CodeHPG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALES is the device name listed in this FDA 510(k) record. The listed applicant is Oms. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K823385. The device is classified under product code HPG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALES?

ALES is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Oms. The 510(k) number is K823385.

When did ALES receive FDA 510(k) clearance?

ALES received FDA 510(k) clearance on 1983-03-09, under 510(k) number K823385.

Who is the listed applicant for ALES?

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

What is the FDA product code for ALES?

The FDA product code for ALES is HPG.

Related PubMed Literature

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.

PMID: 42290427Reliability and Consistency Analysis of Multiple Instruments for Scoliosis Screening in Adolescent Males: A Comparative Study of Instrument Accuracy.Studies in health technology and informatics ()PMID: 37162363Multicenter Clinical Performance Evaluation of Omadacycline Susceptibility Testing of Enterobacterales on VITEK 2 Systems.Journal of clinical microbiology ()

Related Devices (Code: HPG)

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.

K910601PATHFINDERNurion IndustriesK910124LOW VISION ENHANCEMENT SYSTEM (LVES)Triangle InvestmentsK903558LASER CANENurion IndustriesK902187POLARONNurion IndustriesK862338SENSORY 6Brytech, Inc.K761215F4912 NIGHT VISION AIDItt Corp.

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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