CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252

Stimulator, Nerve, Battery-powered

FISHER & PAYKEL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Constant Current Peripheral Nerve Stim. #ns252.

Pre-market Notification Details

Device IDK882438
510k NumberK882438
Device Name:CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
ClassificationStimulator, Nerve, Battery-powered
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand,  NZ
ContactDavid Milburn
CorrespondentDavid Milburn
FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand,  NZ
Product CodeBXN  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-14
Decision Date1988-07-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.