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FDA 510(k)

STIMULATOR MODEL SSS-1101

K-Number: K791149 · 1979-09-17

ApplicantNihon Kohden America, Inc.
Decision Date1979-09-17
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STIMULATOR MODEL SSS-1101 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1979-09-17 under 510(k) number K791149. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMULATOR MODEL SSS-1101?

STIMULATOR MODEL SSS-1101 is a medical device that received FDA 510(k) clearance on 1979-09-17. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K791149.

When did STIMULATOR MODEL SSS-1101 receive FDA 510(k) clearance?

STIMULATOR MODEL SSS-1101 received FDA 510(k) clearance on 1979-09-17, under 510(k) number K791149.

Who is the listed applicant for STIMULATOR MODEL SSS-1101?

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

What is the FDA product code for STIMULATOR MODEL SSS-1101?

The FDA product code for STIMULATOR MODEL SSS-1101 is GWE.

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Other records listing Nihon Kohden America, 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.

K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXK120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT PK092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMK083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PK083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYK082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES

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Related Devices (Code: GWE)

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.

K221471E3 and ProfileDiagnosys, LLCK212936Vision Monitor- MonCvONEMetrovisionK211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovisionK200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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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