Question 1

Who is the manufacturer of CLEAN CUFF BLOOD PRESSURE CUFF LINER?

Accepted Answer

Steridyne Corp. filed the 510(k) submission for CLEAN CUFF BLOOD PRESSURE CUFF LINER (K925352).

Question 2

What is the FDA product code for CLEAN CUFF BLOOD PRESSURE CUFF LINER?

Accepted Answer

DXQ. It is classified under 21 CFR 870.1120 as a Class 2 device in the Cardiovascular panel.

Question 3

When was CLEAN CUFF BLOOD PRESSURE CUFF LINER cleared by the FDA?

Accepted Answer

Jan 12, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for CLEAN CUFF BLOOD PRESSURE CUFF LINER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CLEAN CUFF BLOOD PRESSURE CUFF LINER?

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	K925352
Device Name	CLEAN CUFF BLOOD PRESSURE CUFF LINER
Applicant	Steridyne Corp.
Product Code	DXQ · Cardiovascular
Decision Date	Jan 12, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1120
Device Class	Class 2

CLEAN CUFF BLOOD PRESSURE CUFF LINER

Device Facts

Regulatory Classification

Identification