FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

K955018

Device Name

TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR

Manufacturer

INSTRUMENTARIUM CORP.

Date Cleared

1996-01-30

(89 days)

Product Code

FFT

Regulation Number

876.1400

Intended Use

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 876.1400 Stomach pH electrode.

(a)
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.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Summary

N/A