FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUDIOMETER, PORTABLE, AIR CONDUCTION
K Number: K780382
·
Decision Mar 14, 1978
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
234
Applicant Total
58
Review Days
4
Basic Information
- Device Name
- AUDIOMETER, PORTABLE, AIR CONDUCTION
- K Number
- K780382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- MAICO HEARING INSTRUMENTS, INC.
- Date Received
- March 10, 1978
- Decision Date
- March 14, 1978
- Product Code
- EWO
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by MAICO HEARING INSTRUMENTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K960031 | AUDIOFLEX 120 | Mar 7, 1996 | Substantially Equivalent |
| K954054 | MAICO PRODIGY CIC SERIES | Sep 28, 1995 | Substantially Equivalent |
| K953161 | MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION | Jul 24, 1995 | Substantially Equivalent |
| K950637 | MAICO IN-THE-EAR MODEL RD-312 CIC | Mar 21, 1995 | Substantially Equivalent |
| K946253 | MAICO IN-THE-EAR MODEL RD 201 | Jan 30, 1995 | Substantially Equivalent |
| K931322 | KS 5 - CLINICAL AUDIOMETER | Aug 19, 1994 | Substantially Equivalent |
| K933291 | MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID | Aug 23, 1993 | Substantially Equivalent |
| K930112 | MAICO MA790 AUDIOMETER | Aug 5, 1993 | Substantially Equivalent |
| K926439 | MA25 - PORTABLE AUDIOMETER, MODIFICATION | Aug 5, 1993 | Substantially Equivalent |
| K931160 | SERIES STAR 66 BEKHIND THE EAR HEARING AID | Jun 1, 1993 | Substantially Equivalent |