D.L. SCOPE(R) OTOSCOPE— 510(k) K862661
Substantially EquivalentNorth American Medical Products, Inc.
FDA 510(k) clearance K862661 for D.L. SCOPE(R) OTOSCOPE, Substantially Equivalent on 1986-08-08. Applicant: North American Medical Products, Inc.. Device class: 1.
Clearance details
- Applicant
- North American Medical Products, Inc.
- Product code
- Code ERA
- Device class
- Class 1
- Regulation
- 21 CFR 874.4770
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Loudonville, NY, US
Recent devices under product code ERA
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