Question 1

Who is the manufacturer of OPHTHALMIC CHAIR?

Accepted Answer

Luneau Laboratories filed the 510(k) submission for OPHTHALMIC CHAIR (K844362).

Question 2

What is the FDA product code for OPHTHALMIC CHAIR?

Accepted Answer

HMF. It is classified under 21 CFR 886.1860 as a Class 1 device in the Ophthalmic panel.

Question 3

When was OPHTHALMIC CHAIR cleared by the FDA?

Accepted Answer

Dec 11, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for OPHTHALMIC CHAIR?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like OPHTHALMIC CHAIR?

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	K844362
Device Name	OPHTHALMIC CHAIR
Applicant	Luneau Laboratories
Product Code	HMF · Ophthalmic
Decision Date	Dec 11, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.1860
Device Class	Class 1

OPHTHALMIC CHAIR

Device Facts

Regulatory Classification

Identification