Question 1

Who is the manufacturer of IMEDGE VIDEO OSTOSCOPE (ANALOG)?

Accepted Answer

Introspect, Inc. filed the 510(k) submission for IMEDGE VIDEO OSTOSCOPE (ANALOG) (K951255).

Question 2

What is the FDA product code for IMEDGE VIDEO OSTOSCOPE (ANALOG)?

Accepted Answer

ERA. It is classified under 21 CFR 874.4770 as a Class 1 device in the Ear, Nose, Throat panel.

Question 3

When was IMEDGE VIDEO OSTOSCOPE (ANALOG) cleared by the FDA?

Accepted Answer

Apr 13, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for IMEDGE VIDEO OSTOSCOPE (ANALOG)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like IMEDGE VIDEO OSTOSCOPE (ANALOG)?

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	K951255
Device Name	IMEDGE VIDEO OSTOSCOPE (ANALOG)
Applicant	Introspect, Inc.
Product Code	ERA · Ear, Nose, Throat
Decision Date	Apr 13, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4770
Device Class	Class 1

IMEDGE VIDEO OSTOSCOPE (ANALOG)

Device Facts

Regulatory Classification

Identification