FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHILIPS MODEL S47 BTE HEARING AID
K Number: K910206
·
Decision Feb 5, 1991
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
20
Review Days
20
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Basic Information
- Device Name
- PHILIPS MODEL S47 BTE HEARING AID
- K Number
- K910206
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Philips Hearing Instruments Co.
- Date Received
- January 16, 1991
- Decision Date
- February 5, 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 Philips Hearing Instruments Co.
| K Number | Device Name | ||
|---|---|---|---|
| K972818 | D72 DIGITAL | Oct 17, 1997 | Substantially Equivalent |
| K971804 | PHILIPS S1694, S1695 | Jun 6, 1997 | Substantially Equivalent |
| K965088 | M11 SERIES: M11, M11M | Jan 24, 1997 | Substantially Equivalent |
| K961770 | PHILIPS 71 SERIES | Aug 2, 1996 | Substantially Equivalent |
| K952658 | HEARING AID | Jul 28, 1995 | Substantially Equivalent |
| K944404 | MO4 SERIES | Dec 27, 1994 | Substantially Equivalent |
| K943670 | MO6 SERIES | Aug 18, 1994 | Substantially Equivalent |
| K943395 | PHILIPS M38 SERIES | Aug 9, 1994 | Substantially Equivalent |
| K942164 | PHILIPS 61 SERIES | Jun 17, 1994 | Substantially Equivalent |
| K933850 | PHILIPS 45 SERIES | Sep 7, 1993 | Substantially Equivalent |