ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80— 510(k) K032954
Substantially EquivalentDanmeter A/S
FDA 510(k) clearance K032954 for ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80, Substantially Equivalent on 2004-08-09. Applicant: Danmeter A/S. Device class: 2.
Clearance details
- Applicant
- Danmeter A/S
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Odense C, DK
Recent devices under product code IPF
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