FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

K001467

Device Name

DA VINCHI EMG/EP ISA1004EP

Manufacturer

AIRSEP CORP.

Date Cleared

2000-08-01

(83 days)

Product Code

GWE GWF GWJ

Regulation Number

882.1890

Intended Use

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 882.1890 Evoked response photic stimulator.

(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).

Summary

N/A