FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID
K Number: K870691
·
Decision Mar 13, 1987
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
31
Review Days
22
Basic Information
- Device Name
- DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID
- K Number
- K870691
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- DAHLBERG ELECTRONICS, INC.
- Date Received
- February 19, 1987
- Decision Date
- March 13, 1987
- 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 DAHLBERG ELECTRONICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K896157 | DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID | Jan 22, 1990 | Substantially Equivalent |
| K896158 | DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID | Jan 22, 1990 | Substantially Equivalent |
| K896159 | DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID | Jan 22, 1990 | Substantially Equivalent |
| K881417 | DAHLBERG MODEL GP BODY AID | Jun 7, 1988 | Substantially Equivalent |
| K881612 | DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID | Jun 1, 1988 | Substantially Equivalent |
| K874831 | AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID | Feb 22, 1988 | Substantially Equivalent |
| K874830 | MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID | Feb 17, 1988 | Substantially Equivalent |
| K873169 | DAHLBERG MODEL GH BODY AID | Sep 16, 1987 | Substantially Equivalent |
| K873376 | MODEL SI AND SP BEHIND-THE-EAR HEARING AID | Sep 14, 1987 | Substantially Equivalent |
| K873397 | DAHLBERG MODEL MH BEHIND-THE-EAR HEARING AID | Sep 14, 1987 | Substantially Equivalent |