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FDA 510(k)

ELECTRO-MESH

K-Number: K932299 · 1994-07-01

ApplicantPrizm Medical, Inc.
Decision Date1994-07-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRO-MESH is the device name listed in this FDA 510(k) record. The listed applicant is Prizm Medical, Inc.. It received FDA 510(k) clearance on 1994-07-01 under 510(k) number K932299. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO-MESH?

ELECTRO-MESH is a medical device that received FDA 510(k) clearance on 1994-07-01. The listed applicant is Prizm Medical, Inc.. The 510(k) number is K932299.

When did ELECTRO-MESH receive FDA 510(k) clearance?

ELECTRO-MESH received FDA 510(k) clearance on 1994-07-01, under 510(k) number K932299.

Who is the listed applicant for ELECTRO-MESH?

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

What is the FDA product code for ELECTRO-MESH?

The FDA product code for ELECTRO-MESH is GXY.

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Other records listing Prizm Medical, 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.

K0331225000Z SYSTEM (OTC)K032239THERA-CREAM, MODEL TCT004K024181PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEMK012974PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007K951727Z-WATCH SYSTEMK944487ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES

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Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

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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