Question 1

Who is the manufacturer of PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL?

Accepted Answer

Phonic Ear, Inc. filed the 510(k) submission for PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL (K874304).

Question 2

What is the FDA product code for PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL?

Accepted Answer

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

Question 3

When was PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL cleared by the FDA?

Accepted Answer

Nov 20, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL?

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	K874304
Device Name	PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL
Applicant	Phonic Ear, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Nov 20, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3300
Device Class	Class 1

PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL

Device Facts

Regulatory Classification

Identification