N 800 HF— 510(k) K950037
Substantially EquivalentOldelft Corp. of America
FDA 510(k) clearance K950037 for N 800 HF, Substantially Equivalent on 1995-02-15. Applicant: Oldelft Corp. of America. Device class: 1.
Clearance details
- Applicant
- Oldelft Corp. of America
- Product code
- Code IZO
- Device class
- Class 1
- Regulation
- 21 CFR 892.1700
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfax, VA, US
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