PHONIC EAR MODEL PE 810S— 510(k) K820172
Substantially EquivalentPhonic Ear, Inc.
FDA 510(k) clearance K820172 for PHONIC EAR MODEL PE 810S, Substantially Equivalent on 1982-02-24. 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
- Mchenry, IL, 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.