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FDA 510(k)

QUANTUM 412

K-Number: K844570 · 1984-12-05

ApplicantKeta Corp.
Decision Date1984-12-05
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

QUANTUM 412 is the device name listed in this FDA 510(k) record. The listed applicant is Keta Corp.. It received FDA 510(k) clearance on 1984-12-05 under 510(k) number K844570. The device is classified under product code HPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTUM 412?

QUANTUM 412 is a medical device that received FDA 510(k) clearance on 1984-12-05. The listed applicant is Keta Corp.. The 510(k) number is K844570.

When did QUANTUM 412 receive FDA 510(k) clearance?

QUANTUM 412 received FDA 510(k) clearance on 1984-12-05, under 510(k) number K844570.

Who is the listed applicant for QUANTUM 412?

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

What is the FDA product code for QUANTUM 412?

The FDA product code for QUANTUM 412 is HPT.

Related Clinical Trials

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.

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Other records listing Keta Corp. 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.

K861027KETA HAND-HELD TONOMETERK861028SUPERLITE PENLIGHT

Related Devices (Code: HPT)

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.

K092187MAIA, MODEL 1Centervue S.P.A.K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESCarl Zeiss Meditec, Inc.K091579FORESEE HOMENotal Vision , Ltd.K063310TRUEFIELD ANALYZERSeeing Machines LimitedK050350THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)Notal Vision, Inc.K023623NOVAVISION, MODEL 2.0Novavision, 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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