Question 1

Who is the manufacturer of ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)?

Accepted Answer

Icor AB filed the 510(k) submission for ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) (K952325).

Question 2

What is the FDA product code for ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)?

Accepted Answer

CCK. It is classified under 21 CFR 868.1400 as a Class 2 device in the Anesthesiology panel.

Question 3

When was ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) cleared by the FDA?

Accepted Answer

Jul 31, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)?

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	K952325
Device Name	ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
Applicant	Icor AB
Product Code	CCK · Anesthesiology
Decision Date	Jul 31, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

Device Facts

Regulatory Classification

Identification