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FDA 510(k)

KOI PACHYMETER

K-Number: K843247 · 1986-04-30

ApplicantKoi, Inc.
Decision Date1986-04-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KOI PACHYMETER is the device name listed in this FDA 510(k) record. The listed applicant is Koi, Inc.. It received FDA 510(k) clearance on 1986-04-30 under 510(k) number K843247. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOI PACHYMETER?

KOI PACHYMETER is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is Koi, Inc.. The 510(k) number is K843247.

When did KOI PACHYMETER receive FDA 510(k) clearance?

KOI PACHYMETER received FDA 510(k) clearance on 1986-04-30, under 510(k) number K843247.

Who is the listed applicant for KOI PACHYMETER?

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

What is the FDA product code for KOI PACHYMETER?

The FDA product code for KOI PACHYMETER is ITX.

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Other records listing Koi, Inc. 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.

K830366DIAMOND KNIFEK812764KOI BLUE FIELD ENTOPTOSCOPEK812450KOI DIAMOND KNIFEK812097KOI LACREMAL HOOK & DILATORK812010KOI LACRIMAL INTUBATION SYSTEMK812011BLADE GAUGE

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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