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

FDA 510(k) Search

K Number

K954501

Device Name

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM

Manufacturer

MEDTRONIC BIO-MEDICUS, INC.

Date Cleared

1996-01-16

(110 days)

Product Code

DTY

Regulation Number

870.4410

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

§ 870.4410 Cardiopulmonary bypass in-line blood gas sensor.

(a)
Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.(b)
Classification. Class II (performance standards).

Summary

N/A