FDA 510(k) Premarket Notification K860126: STIMUPLEX, NERVE STIMULATOR

Submission Details & Decision

Normalized public record details for 510(k) notification K860126.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K860126

Applicant / Sponsor

Burron Medical Products, Inc.

Device Name

STIMUPLEX, NERVE STIMULATOR

Product Code

BXN

Decision Date

1986-02-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Traditional

Third Party Flag

Date Received

1986-01-14

Related Establishments / Registrations

SunMed Group Holdings, LLC Registration: 1314417 View Registration
Anesthesia Associates, Inc. Registration: 2022648 View Registration
FISHER & PAYKEL HEALTHCARE, INC. Registration: 2085602 View Registration
NORTECH SYSTEMS, INC. Registration: 2183613 View Registration
B. BRAUN US DEVICE MANUFACTURING LLC Registration: 2523676 View Registration
Suzhou Meccan Import and Export Corp. Registration: 3001650535 View Registration
EASYMED INSTRUMENTS CO., LTD. Registration: 3004049909 View Registration
Salter Labs Registration: 3004748541 View Registration
Natus Manufacturing Limited Registration: 3005581270 View Registration
XAVANT TECHNOLOGY (PTY) LTD Registration: 3007699086 View Registration
PAUL E. DANCHELL A/S Registration: 3008773490 View Registration
HA2 MEDIZINTECHNIK GMBH Registration: 3009039068 View Registration
B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
STOCKERT GMBH Registration: 3015537323 View Registration
B. BRAUN MELSUNGEN AG Registration: 9610825 View Registration
FISHER & PAYKEL HEALTHCARE, LTD. Registration: 9611451 View Registration
HAKKO CO., LTD. Registration: 9611481 View Registration
PAJUNK GMBH MEDIZINTECHNOLOGIE Registration: 9611612 View Registration
BOWA-ELECTRONIC GMBH & CO. KG Registration: 9614969 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.