Mui Scientific BE8(50)

• FDA 510(k) K823701 decided 15 Feb 1983 Active
• FDA GUDID UDI-DI 00678467005335 listed 15 Oct 2019 Listed

1. 15 Feb 1983 Cleared FDA 510(k) K823701
2. 15 Oct 2019 Listed FDA GUDID 00678467005335

Trade name

Mui Scientific

Generic name

Gastrointestinal motility manometric catheter, non-electronic

Model / reference

BE8(50)

Primary DI / UDI-DI

00678467005335

510(k) Number

K823701 ↗

FDA product code

FFX

GMDN term

Gastrointestinal motility manometric catheter, non-electronic

Device class

Class II

Regulation number

876.1725

GUDID distribution status

In Commercial Distribution

Category: Gastrointestinal motility manometric catheter, non-electronic

Other devices filed under FDA product code FFX (System, Gastrointestinal Motility (Electrical)).

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• Endoflip EF-302 by Covidien LP
• EndoFLIP System by Crospon, Ltd.
• Rapid Barostat Bag (RBB) Pump and Catheter System by Mui Scientific
• POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 by Medtronic Functional Diagnostics A/S
• GAELTEC MPR SERIES by Medical Measurements, Inc.
• GASTROSCAN by Medics Instrument Corp.
• EndoflipTM 300 System by Covidien llc

• Mui Scientific CE5-1088

  Class II

  CE/MDR 28620121250-03 Expiring Valid to Jan 2027 FDA 510(k) K983665 Active Cleared 17 May 1999 +1authorizations

• Mui Scientific S7-E22-1004

  Class II

  FDA 510(k) K823701 Active Cleared 15 Feb 1983 GUDID on market

• Mui Scientific S7-R24-1045

  Class II

  FDA 510(k) K823701 Active Cleared 15 Feb 1983 GUDID on market

• Mui Scientific S7-R24-1047

  Class II

  FDA 510(k) K823701 Active Cleared 15 Feb 1983 GUDID on market

See all devices from H & A Mui Enterprises Inc →