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FDA 510(k)

KETA HAND-HELD TONOMETER

K-Number: K861027 · 1986-05-06

ApplicantKeta Corp.
Decision Date1986-05-06
Product CodeHKS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KETA HAND-HELD TONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Keta Corp.. It received FDA 510(k) clearance on 1986-05-06 under 510(k) number K861027. The device is classified under product code HKS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KETA HAND-HELD TONOMETER?

KETA HAND-HELD TONOMETER is a medical device that received FDA 510(k) clearance on 1986-05-06. The listed applicant is Keta Corp.. The 510(k) number is K861027.

When did KETA HAND-HELD TONOMETER receive FDA 510(k) clearance?

KETA HAND-HELD TONOMETER received FDA 510(k) clearance on 1986-05-06, under 510(k) number K861027.

Who is the listed applicant for KETA HAND-HELD TONOMETER?

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

What is the FDA product code for KETA HAND-HELD TONOMETER?

The FDA product code for KETA HAND-HELD TONOMETER is HKS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Keta Corp. 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.

K861028SUPERLITE PENLIGHTK844570QUANTUM 412

Related Devices (Code: HKS)

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.

K935302OSHER SURGICAL GONIO/POSTERIOR POLE LENSOcular Instruments, Inc.K895846TWO MIRROR GONIO LENSOcular Instruments, Inc.K890977MCINTYRE SURGICAL GONIOLENSOcular Instruments, Inc.K862713ABRAHAM IRIDECTOMY LENS (YAG LASER)Ocular Instruments, Inc.K862692KARICKHOFF DIAGNOSTIC/LASER LENSOcular Instruments, Inc.K862024SUSSMAN FOUR MIRROR HAND HELD GONIOPRISMOcular Instruments, 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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