PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL— 510(k) K874304
Substantially EquivalentPhonic Ear, Inc.
FDA 510(k) clearance K874304 for PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL, Substantially Equivalent on 1987-11-20. Applicant: Phonic Ear, Inc.. Device class: 1.
Clearance details
- Applicant
- Phonic Ear, Inc.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mill Valley, CA, US
Recent devices under product code ESD
view allMore clearances from Phonic Ear, Inc.
view all- K043090 — EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
- K974658 — INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
- K974287 — FM RECEIVER - AUDITORY TRAINER
- K950730 — GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
- K940313 — PHONIC EAR
Data sourced from openFDA. This site is unofficial and independent of the FDA.