FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
K Number: K971845
·
Decision Aug 15, 1997
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
1
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
- K Number
- K971845
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sound Hearing Instruments, Inc.
- Date Received
- May 19, 1997
- Decision Date
- August 15, 1997
- Product Code
- ESD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESD), ordered by most recent decision date.
Lyric4 Hearing Aid
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC2
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INSOUND XT SERIES HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat