Question 1

Who is the manufacturer of DHD EMERALD PRODUCT?

Accepted Answer

Dhd Diemolding Healthcare Div. filed the 510(k) submission for DHD EMERALD PRODUCT (K970596).

Question 2

What is the FDA product code for DHD EMERALD PRODUCT?

Accepted Answer

BWF. It is classified under 21 CFR 868.5690 as a Class 2 device in the Anesthesiology panel.

Question 3

When was DHD EMERALD PRODUCT cleared by the FDA?

Accepted Answer

May 16, 1997 (decision: SESE).

Question 4

What is the regulatory pathway for DHD EMERALD PRODUCT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DHD EMERALD PRODUCT?

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	K970596
Device Name	DHD EMERALD PRODUCT
Applicant	Dhd Diemolding Healthcare Div.
Product Code	BWF · Anesthesiology
Decision Date	May 16, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5690
Device Class	Class 2

DHD EMERALD PRODUCT

Device Facts

Regulatory Classification

Identification