Question 1

Who is the manufacturer of ANEROID SPHYMOMANOMETER?

Accepted Answer

Abco Dealers, Inc. filed the 510(k) submission for ANEROID SPHYMOMANOMETER (K792355).

Question 2

What is the FDA product code for ANEROID SPHYMOMANOMETER?

Accepted Answer

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

Question 3

When was ANEROID SPHYMOMANOMETER cleared by the FDA?

Accepted Answer

Dec 5, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for ANEROID SPHYMOMANOMETER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ANEROID SPHYMOMANOMETER?

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	K792355
Device Name	ANEROID SPHYMOMANOMETER
Applicant	Abco Dealers, Inc.
Product Code	DXQ · Cardiovascular
Decision Date	Dec 5, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1120
Device Class	Class 2

ANEROID SPHYMOMANOMETER

Device Facts

Regulatory Classification

Identification