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

HOTMAN

Manufacturer

HEMO SAPIENS, INC.

Date Cleared

1997-06-10

(764 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

HEMO SAPIENS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Not Found

Device Description

HOTMAN (Hemodynamic and Oxygen Transport Monitoring and Manaqing System)

Ask a Question

Ask a specific question about this device

K Number

Device Name

TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)

Manufacturer

HEMO SAPIENS, INC.

Date Cleared

1996-11-21

(171 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

HEMO SAPIENS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

Ask a Question

Ask a specific question about this device

Page 1 of 1