FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 2 results

510(k) Data Aggregation

K Number

Device Name

JAZZY

Manufacturer

PRIDE HEALTH CARE, INC.

Date Cleared

1996-05-28

(540 days)

Product Code

ITI

Regulation Number

890.3860

Why did this record match?

Applicant Name (Manufacturer) :

PRIDE HEALTH CARE, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

K Number

Device Name

EURO SC500

Manufacturer

PRIDE HEALTH CARE, INC.

Date Cleared

1996-02-12

(493 days)

Product Code

INI

Regulation Number

890.3800

Why did this record match?

Applicant Name (Manufacturer) :

PRIDE HEALTH CARE, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

Page 1 of 1