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

MAXIM PF MODELS 033-581/033-590

Manufacturer

TELECTRONICS PACING SYSTEMS, INC.

Date Cleared

1996-07-15

(117 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

TELECTRONICS PACING SYSTEMS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

Ask a Question

Ask a specific question about this device

K Number

Device Name

STERILIZATION

Manufacturer

TELECTRONICS PACING SYSTEMS, INC.

Date Cleared

1996-06-24

(698 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

TELECTRONICS PACING SYSTEMS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Summaries of Equivalence for 510(k) for life supporting, life sustaining and implantable devices. These summaries should: Specify the device or devices to which the manufacturer is claiming equivalence design, materials (for devices which are implants or which are designed to to come into contact with the body), performance and indications.

Device Description

Not Found

Ask a Question

Ask a specific question about this device

Page 1 of 1