FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHILIPS M38 SERIES
K Number: K943395
·
Decision Aug 9, 1994
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
20
Review Days
26
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
- PHILIPS M38 SERIES
- K Number
- K943395
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Philips Hearing Instruments Co.
- Date Received
- July 14, 1994
- Decision Date
- August 9, 1994
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESD), ordered by most recent decision date.
Lyric4 Hearing Aid
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC2
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INSOUND XT SERIES HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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 |
| K942164 | PHILIPS 61 SERIES | Jun 17, 1994 | Substantially Equivalent |
| K933850 | PHILIPS 45 SERIES | Sep 7, 1993 | Substantially Equivalent |
| K921725 | PHILIP XP SERIES, IN-THE CANAL HEARING AID | Aug 11, 1992 | Substantially Equivalent |