TDK MEDICAL GRADE CD-R— 510(k) K971848
Substantially EquivalentTdk Electronics Corporation of America
FDA 510(k) clearance K971848 for TDK MEDICAL GRADE CD-R, Substantially Equivalent on 1997-08-15. Applicant: Tdk Electronics Corporation of America. Device class: 1.
Clearance details
- Applicant
- Tdk Electronics Corporation of America
- Product code
- Code LMB
- Device class
- Class 1
- Regulation
- 21 CFR 892.2010
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Port Washington, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.