FDA 510(k)

GAMMA GOUNTING SYS., AUTO, MODEL 1400

K-Number: K771180 · 1977-08-03

Decision Date1977-08-03

Product CodeJJJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GAMMA GOUNTING SYS., AUTO, MODEL 1400 is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K771180. The device is classified under product code JJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA GOUNTING SYS., AUTO, MODEL 1400?

GAMMA GOUNTING SYS., AUTO, MODEL 1400 is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is G.D. Searle and Co.. The 510(k) number is K771180.

When did GAMMA GOUNTING SYS., AUTO, MODEL 1400 receive FDA 510(k) clearance?

GAMMA GOUNTING SYS., AUTO, MODEL 1400 received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771180.

Who is the listed applicant for GAMMA GOUNTING SYS., AUTO, MODEL 1400?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA GOUNTING SYS., AUTO, MODEL 1400?

The FDA product code for GAMMA GOUNTING SYS., AUTO, MODEL 1400 is JJJ.

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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.