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FDA 510(k)

MODEL 3000 OPHTHALMIC SURGICAL SYSTEM

K-Number: K872312 · 1987-07-15

ApplicantAllergan Humphrey
Decision Date1987-07-15
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 3000 OPHTHALMIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Allergan Humphrey. It received FDA 510(k) clearance on 1987-07-15 under 510(k) number K872312. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3000 OPHTHALMIC SURGICAL SYSTEM?

MODEL 3000 OPHTHALMIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1987-07-15. The listed applicant is Allergan Humphrey. The 510(k) number is K872312.

When did MODEL 3000 OPHTHALMIC SURGICAL SYSTEM receive FDA 510(k) clearance?

MODEL 3000 OPHTHALMIC SURGICAL SYSTEM received FDA 510(k) clearance on 1987-07-15, under 510(k) number K872312.

Who is the listed applicant for MODEL 3000 OPHTHALMIC SURGICAL SYSTEM?

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

What is the FDA product code for MODEL 3000 OPHTHALMIC SURGICAL SYSTEM?

The FDA product code for MODEL 3000 OPHTHALMIC SURGICAL SYSTEM is HQE.

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 Allergan Humphrey 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.

K902582ALLERGAN HUMPHREY A/B SCAN , MODEL 835K871611ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540

Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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