MODEL 30 CLASSIC PNEUMATONOMETER— 510(k) K002395
Substantially EquivalentXomed, Inc.
FDA 510(k) clearance K002395 for MODEL 30 CLASSIC PNEUMATONOMETER, Substantially Equivalent on 2000-12-11. Applicant: Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Xomed, Inc.
- Product code
- Code HKX
- Device class
- Class 2
- Regulation
- 21 CFR 886.1930
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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