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FDA 510(k)

SPECTROPAD SYSTEM

K-Number: K931261 · 1994-03-31

ApplicantSmi
Decision Date1994-03-31
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPECTROPAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smi. It received FDA 510(k) clearance on 1994-03-31 under 510(k) number K931261. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTROPAD SYSTEM?

SPECTROPAD SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-31. The listed applicant is Smi. The 510(k) number is K931261.

When did SPECTROPAD SYSTEM receive FDA 510(k) clearance?

SPECTROPAD SYSTEM received FDA 510(k) clearance on 1994-03-31, under 510(k) number K931261.

Who is the listed applicant for SPECTROPAD SYSTEM?

The FDA 510(k) record lists Smi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTROPAD SYSTEM?

The FDA product code for SPECTROPAD SYSTEM is ILY.

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Official Source

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

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