Question 1

Who is the manufacturer of POST-AURICULAR HEARING AID MODEL PE 600PPCH?

Accepted Answer

Phonic Ear, Inc. filed the 510(k) submission for POST-AURICULAR HEARING AID MODEL PE 600PPCH (K844862).

Question 2

What is the FDA product code for POST-AURICULAR HEARING AID MODEL PE 600PPCH?

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 POST-AURICULAR HEARING AID MODEL PE 600PPCH cleared by the FDA?

Accepted Answer

Apr 8, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for POST-AURICULAR HEARING AID MODEL PE 600PPCH?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like POST-AURICULAR HEARING AID MODEL PE 600PPCH?

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	K844862
Device Name	POST-AURICULAR HEARING AID MODEL PE 600PPCH
Applicant	Phonic Ear, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Apr 8, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3300
Device Class	Class 1

POST-AURICULAR HEARING AID MODEL PE 600PPCH

Device Facts

Regulatory Classification

Identification