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FDA 510(k)

COHERENT FUNDUSL RETINAL CAMERA

K-Number: K822908 · 1983-01-05

ApplicantCoherent Medical Division
Decision Date1983-01-05
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COHERENT FUNDUSL RETINAL CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Medical Division. It received FDA 510(k) clearance on 1983-01-05 under 510(k) number K822908. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COHERENT FUNDUSL RETINAL CAMERA?

COHERENT FUNDUSL RETINAL CAMERA is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is Coherent Medical Division. The 510(k) number is K822908.

When did COHERENT FUNDUSL RETINAL CAMERA receive FDA 510(k) clearance?

COHERENT FUNDUSL RETINAL CAMERA received FDA 510(k) clearance on 1983-01-05, under 510(k) number K822908.

Who is the listed applicant for COHERENT FUNDUSL RETINAL CAMERA?

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

What is the FDA product code for COHERENT FUNDUSL RETINAL CAMERA?

The FDA product code for COHERENT FUNDUSL RETINAL CAMERA is HKI.

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 Coherent Medical Division 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.

K902990COHERENT HOLMIUM:YAG SURGICAL LASERK822415THE OCUPLOT DK801906DIOPTRON III AUTOREFRACTORK801336MODEL 900K PHOTOCOAGULATORK791895ACCESSORIES FOR SYS. 400 CO2 SURG. LASER

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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.

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