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

FDA 510(k) Search

K Number

K960840

Device Name

C.E. VASCULAR MACHINE

Manufacturer

C.E. DIAGNOSIS, INC.

Date Cleared

1997-03-28

(393 days)

Product Code

JEH

Regulation Number

868.1760

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

§ 868.1760 Volume plethysmograph.

(a)
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.(b)
Classification. Class II (performance standards).

Summary

N/A