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FDA 510(k)

VISITEC EYE SPECULUM

K-Number: K843196 · 1984-10-05

ApplicantVisitec Co.
Decision Date1984-10-05
Product CodeHNC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISITEC EYE SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1984-10-05 under 510(k) number K843196. The device is classified under product code HNC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISITEC EYE SPECULUM?

VISITEC EYE SPECULUM is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Visitec Co.. The 510(k) number is K843196.

When did VISITEC EYE SPECULUM receive FDA 510(k) clearance?

VISITEC EYE SPECULUM received FDA 510(k) clearance on 1984-10-05, under 510(k) number K843196.

Who is the listed applicant for VISITEC EYE SPECULUM?

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

What is the FDA product code for VISITEC EYE SPECULUM?

The FDA product code for VISITEC EYE SPECULUM is HNC.

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Other records listing Visitec Co. 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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTS

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Related Devices (Code: HNC)

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.

K022836STEPHENS DISPOSABLE SPECULUMStephens InstrumentsK981235OCULOSTATLaser Center Dev. Corp.K964289EYE FIXATION SPECULUMEyefix, Inc.K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.K863664OPHTHALMIC SURGICAL SPECULUMMyocure, Inc.K830430EYELID SPECULUMDouglas C. Mckee & Co.

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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