FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
K Number: K910018
·
Decision Feb 28, 1991
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
37
Review Days
55
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Basic Information
- Device Name
- POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
- K Number
- K910018
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Phonak, Inc.
- Date Received
- January 4, 1991
- Decision Date
- February 28, 1991
- 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 Phonak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972106 | PHONAK NOVO FORTE E3 | Aug 15, 1997 | Substantially Equivalent |
| K972105 | PHONAK EPICA | Aug 1, 1997 | Substantially Equivalent |
| K972097 | PHONAK MICROZOOM P 2 | Jul 30, 1997 | Substantially Equivalent |
| K964035 | PHONAK MICROLINK, PERSONAL FM RECEIVER | Dec 4, 1996 | Substantially Equivalent |
| K961653 | PHONAK SONA P2 | May 29, 1996 | Substantially Equivalent |
| K961622 | PHONAK PICONET2 P2 AZ | May 17, 1996 | Substantially Equivalent |
| K953921 | PHONAK 9900 CIC | Sep 18, 1995 | Substantially Equivalent |
| K945439 | PHONAK PICONET 232X-AZ HEARING INSTRUMENT | Aug 23, 1995 | Substantially Equivalent |
| K950758 | DYNA 231X | Mar 21, 1995 | Substantially Equivalent |
| K946294 | PHONAK SONO-FORTE 332X-AZ | Jan 26, 1995 | Substantially Equivalent |