FDA 510(k)

LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES

K-Number: K827712 · 1982-08-16

Decision Date1982-08-16

Product Code

DecisionSubstantially Equivalent

Device Summary

LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Cranston Medical Laboratory. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K827712. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES?

LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Cranston Medical Laboratory. The 510(k) number is K827712.

When did LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES receive FDA 510(k) clearance?

LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES received FDA 510(k) clearance on 1982-08-16, under 510(k) number K827712.

Who is the listed applicant for LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES?

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

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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.