FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DAHLBERG HEARING AID MODEL AL
K Number: K820398
·
Decision Mar 2, 1982
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
31
Review Days
19
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Basic Information
- Device Name
- DAHLBERG HEARING AID MODEL AL
- K Number
- K820398
- 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 11, 1982
- Decision Date
- March 2, 1982
- 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 |
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Other Clearances by Dahlberg Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896157 | DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID | Jan 22, 1990 | Substantially Equivalent |
| K896159 | DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID | Jan 22, 1990 | Substantially Equivalent |
| K896158 | DAHLBERG MODEL LA 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 |