Question 1

Who is the manufacturer of BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY?

Accepted Answer

Koven Technology, Inc. filed the 510(k) submission for BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY (K954397).

Question 2

What is the FDA product code for BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY?

Accepted Answer

DPW. It is classified under 21 CFR 870.2100 as a Class 2 device in the Cardiovascular panel.

Question 3

When was BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY cleared by the FDA?

Accepted Answer

Mar 29, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY?

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	K954397
Device Name	BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY
Applicant	Koven Technology, Inc.
Product Code	DPW · Cardiovascular
Decision Date	Mar 29, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2100
Device Class	Class 2

BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY

Device Facts

Regulatory Classification

Identification