FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I22 INITIALES
K Number: K862621
·
Decision Aug 1, 1986
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
55
Applicant Total
57
Review Days
22
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
- I22 INITIALES
- K Number
- K862621
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4770
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Oticon Corp.
- Date Received
- July 10, 1986
- Decision Date
- August 1, 1986
- Product Code
- ERA
- 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 |
|---|---|---|---|
| ERA | Otoscope | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ERA), ordered by most recent decision date.
AIO HD OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LANTOS 3D EAR SCANNER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
OSRAM ITOS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
OPTUS OTOSCOPES
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
WELCH ALLYN BI-OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
WELCH ALLY OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Oticon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K963788 | PRIMOFOCUS COMPACT | Nov 27, 1996 | Substantially Equivalent |
| K932670 | OTICON MF | Aug 5, 1993 | Substantially Equivalent |
| K923490 | BTE HEARING AID PERSONIC 410 | Aug 6, 1992 | Substantially Equivalent |
| K923388 | BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER | Aug 6, 1992 | Substantially Equivalent |
| K923491 | BTE HEARING AID PERSONIC 425 | Aug 6, 1992 | Substantially Equivalent |
| K905555 | A-ZILICONE | Jul 6, 1992 | Substantially Equivalent |
| K904673 | OTICAON BTE MODEL E34P | Nov 1, 1990 | Substantially Equivalent |
| K902559 | CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P | Jul 9, 1990 | Substantially Equivalent |
| K902351 | CUSTOM ITE HEARING AID MODELS C AND M | Jun 14, 1990 | Substantially Equivalent |
| K902352 | CUSTOM ITE HEARING AID MODEL: H | Jun 14, 1990 | Substantially Equivalent |