FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
780 SE (BEHIND THE EAR)
K Number: K780915
·
Decision Jun 14, 1978
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
14
Review Days
9
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Basic Information
- Device Name
- 780 SE (BEHIND THE EAR)
- K Number
- K780915
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Argosy Intl. (Usa), Inc.
- Date Received
- June 5, 1978
- Decision Date
- June 14, 1978
- 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 Argosy Intl. (Usa), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823075 | REXTON | Nov 8, 1982 | Substantially Equivalent |
| K791548 | REXTON HS(HEARING SYSTEM) | Sep 28, 1979 | Substantially Equivalent |
| K781095 | HEARING AID, BEHIND THE EAR | Jul 17, 1978 | Substantially Equivalent |
| K781094 | HEARING AID, EYEGLASS | Jul 17, 1978 | Substantially Equivalent |
| K781096 | HEARING AID, EYEGLASS, B-12 | Jul 17, 1978 | Substantially Equivalent |
| K780921 | MM-CE DM (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |
| K780914 | PM 25 PP (BODY AID) | Jun 14, 1978 | Substantially Equivalent |
| K780920 | MM-CE 11 (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |
| K780916 | 780 UE (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |
| K780917 | PRIMO CE (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |