Who is the manufacturer of LOT 440?

Medical Instruments Corporation Mic AG submitted the Traditional clearance for LOT 440 (K950087).

What is the FDA product code for LOT 440?

FFT. It is classified under 21 CFR 876.1400 as a Class 1 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for LOT 440?

510(k) clearance (submission type: Traditional).

LOT 440

K950087 · Medical Instruments Corporation Mic AG · FFT · Feb 6, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K950087
Device Name	LOT 440
Applicant	Medical Instruments Corporation Mic AG
Product Code	FFT · Gastroenterology, Urology
Decision Date	Feb 6, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1400
Device Class	Class 1

Regulatory Classification

Identification

A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.