HEARTLAND TECHNOLOGIES, ITE, ITC, CIC— 510(k) K971845
Substantially EquivalentSound Hearing Instruments, Inc.
FDA 510(k) clearance K971845 for HEARTLAND TECHNOLOGIES, ITE, ITC, CIC, Substantially Equivalent on 1997-08-15. Applicant: Sound Hearing Instruments, Inc.. Device class: 1.
Clearance details
- Applicant
- Sound Hearing Instruments, 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
- Minneapolis, MN, US
Recent devices under product code ESD
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