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FDA 510(k)

PMT-OPTICA LINE

K-Number: K831118 · 1984-01-25

ApplicantPmt, Inc.
Decision Date1984-01-25
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PMT-OPTICA LINE is the device name listed in this FDA 510(k) record. The listed applicant is Pmt, Inc.. It received FDA 510(k) clearance on 1984-01-25 under 510(k) number K831118. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMT-OPTICA LINE?

PMT-OPTICA LINE is a medical device that received FDA 510(k) clearance on 1984-01-25. The listed applicant is Pmt, Inc.. The 510(k) number is K831118.

When did PMT-OPTICA LINE receive FDA 510(k) clearance?

PMT-OPTICA LINE received FDA 510(k) clearance on 1984-01-25, under 510(k) number K831118.

Who is the listed applicant for PMT-OPTICA LINE?

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

What is the FDA product code for PMT-OPTICA LINE?

The FDA product code for PMT-OPTICA LINE is KDC.

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 Pmt, 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.

K831117MICROMAT W/VARIOUS MODELSK831119LUO CURRETTES #3211

Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstylesK920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, 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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