Device

Apparatus, air handling, room

Regulation Description

Air-handling apparatus for a durgical operating room

Regulation Medical Specialty

General & Plastic Surgery

Review Panel

General & Plastic Surgery

Product Code

FZH

Premarket Review

Surgical and Intection Control Devices 6(OHT4)

General Surgery Devices (DHT4A)

Submission Type

510(K) Exempt

Regulation Number

878. 5070 7

Device Class

2

Total Product Life Cycle(TPLC)

TPLC Product Code Report 8

GMP Exempt?

No

Summary Malfunction Report

Eligible

Note :
Class Ⅱ devices the Food and Drug Administration(FDA) has also published a list of Class Ⅱ (special controls) devices subject to certain imitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997(FDAMA) and the 21st Century Cures Act of 2016(Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirement of FDAMA and the Cures Act.

Implanted Device?

No

Life- Sustain Support Device?

No

Third Party Review

Not Third Party Eligible