M11 SERIES: M11, M11M— 510(k) K965088
Substantially EquivalentPhilips Hearing Instruments Co.
FDA 510(k) clearance K965088 for M11 SERIES: M11, M11M, Substantially Equivalent on 1997-01-24. Applicant: Philips Hearing Instruments Co.. Device class: 1.
Clearance details
- Applicant
- Philips Hearing Instruments Co.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code ESD
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