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

FDA 510(k) Search

K Number

K964360

Device Name

VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101

Manufacturer

NOVAMETRIX MEDICAL SYSTEMS, INC.

Date Cleared

1997-04-04

(154 days)

Product Code

BZC

Regulation Number

868.1880

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

§ 868.1880 Pulmonary-function data calculator.

(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).

Summary

N/A