OTOSCOPE, DIAG. MODELS 20100 & 20200— 510(k) K781029
Substantially EquivalentWelch Allyn, Inc.
FDA 510(k) clearance K781029 for OTOSCOPE, DIAG. MODELS 20100 & 20200, Substantially Equivalent on 1978-06-28. Applicant: Welch Allyn, Inc.. Device class: 1.
Clearance details
- Applicant
- Welch Allyn, 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
- Mchenry, IL, US
Recent devices under product code ERA
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