Question 1

Who is the manufacturer of OPERATING ROOM STAND?

Accepted Answer

Healthmate, Inc. filed the 510(k) submission for OPERATING ROOM STAND (K840027).

Question 2

What is the FDA product code for OPERATING ROOM STAND?

Accepted Answer

FSE. It is classified under 21 CFR 878.4950 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was OPERATING ROOM STAND cleared by the FDA?

Accepted Answer

Feb 4, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for OPERATING ROOM STAND?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like OPERATING ROOM STAND?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K840027
Device Name	OPERATING ROOM STAND
Applicant	Healthmate, Inc.
Product Code	FSE · General, Plastic Surgery
Decision Date	Feb 4, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4950
Device Class	Class 1

OPERATING ROOM STAND

Device Facts

Regulatory Classification

Identification