FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEARTECH MODEL CH
K Number: K853219
·
Decision Sep 23, 1985
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
11
Review Days
53
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
- HEARTECH MODEL CH
- K Number
- K853219
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Hearing Tech, Inc.
- Date Received
- August 1, 1985
- Decision Date
- September 23, 1985
- 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
Other Clearances by Hearing Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941587 | HEARING TECH | Jun 24, 1994 | Substantially Equivalent |
| K924712 | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM | Dec 8, 1992 | Substantially Equivalent |
| K905680 | 543 SERIES BTE | Mar 8, 1991 | Substantially Equivalent |
| K903295 | ESCORT ITC | Sep 5, 1990 | Substantially Equivalent |
| K903023 | HERITAGE III (HTC) ITC TYPE HEARING AID | Jul 27, 1990 | Substantially Equivalent |
| K870723 | HEARTECH HFX, HEARING AID | Mar 20, 1987 | Substantially Equivalent |
| K870350 | ESCORT EC CUSTOM IN-THE-EAR HEARING AID | Mar 11, 1987 | Substantially Equivalent |
| K854315 | HEARTECH MODEL IN TECH | Jan 21, 1986 | Substantially Equivalent |
| K853218 | HEARTECH MODEL(HTC) (HERITAGE) | Sep 23, 1985 | Substantially Equivalent |
| K853220 | HEARTECH MODEL ILLUSION | Sep 23, 1985 | Substantially Equivalent |