Question 1

Who is the manufacturer of DORNIR LC-1 CPAP SYSTEM?

Accepted Answer

Prym Medical , Ltd. filed the 510(k) submission for DORNIR LC-1 CPAP SYSTEM (K010704).

Question 2

What is the FDA product code for DORNIR LC-1 CPAP SYSTEM?

Accepted Answer

BZD. It is classified under 21 CFR 868.5905 as a Class 2 device in the Anesthesiology panel.

Question 3

When was DORNIR LC-1 CPAP SYSTEM cleared by the FDA?

Accepted Answer

Apr 18, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for DORNIR LC-1 CPAP SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DORNIR LC-1 CPAP SYSTEM?

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	K010704
Device Name	DORNIR LC-1 CPAP SYSTEM
Applicant	Prym Medical , Ltd.
Product Code	BZD · Anesthesiology
Decision Date	Apr 18, 2001
Decision	SESE
Submission Type	Special
Regulation	21 CFR 868.5905
Device Class	Class 2

DORNIR LC-1 CPAP SYSTEM

Device Facts

Regulatory Classification

Identification