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FDA 510(k)

TDK MEDICAL GRADE CD-R

K-Number: K971848 · 1997-08-15

ApplicantTdk Electronics Corporation of America
Decision Date1997-08-15
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TDK MEDICAL GRADE CD-R is the device name listed in this FDA 510(k) record. The listed applicant is Tdk Electronics Corporation of America. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K971848. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDK MEDICAL GRADE CD-R?

TDK MEDICAL GRADE CD-R is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Tdk Electronics Corporation of America. The 510(k) number is K971848.

When did TDK MEDICAL GRADE CD-R receive FDA 510(k) clearance?

TDK MEDICAL GRADE CD-R received FDA 510(k) clearance on 1997-08-15, under 510(k) number K971848.

Who is the listed applicant for TDK MEDICAL GRADE CD-R?

The FDA 510(k) record lists Tdk Electronics Corporation of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TDK MEDICAL GRADE CD-R?

The FDA product code for TDK MEDICAL GRADE CD-R is LMB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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