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FDA 510(k)

DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU

K-Number: K850191 · 1985-03-04

ApplicantBio-Rad
Decision Date1985-03-04
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1985-03-04 under 510(k) number K850191. 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 DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU?

DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU is a medical device that received FDA 510(k) clearance on 1985-03-04. The listed applicant is Bio-Rad. The 510(k) number is K850191.

When did DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU receive FDA 510(k) clearance?

DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU received FDA 510(k) clearance on 1985-03-04, under 510(k) number K850191.

Who is the listed applicant for DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU?

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

What is the FDA product code for DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU?

The FDA product code for DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU is HPT.

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Other records listing Bio-Rad as applicant

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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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