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FDA 510(k)

INTEGRAL SECTOR MODULE

K-Number: K820124 · 1982-03-05

ApplicantSiemens Gammasonics, Inc.
Decision Date1982-03-05
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTEGRAL SECTOR MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1982-03-05 under 510(k) number K820124. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRAL SECTOR MODULE?

INTEGRAL SECTOR MODULE is a medical device that received FDA 510(k) clearance on 1982-03-05. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K820124.

When did INTEGRAL SECTOR MODULE receive FDA 510(k) clearance?

INTEGRAL SECTOR MODULE received FDA 510(k) clearance on 1982-03-05, under 510(k) number K820124.

Who is the listed applicant for INTEGRAL SECTOR MODULE?

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

What is the FDA product code for INTEGRAL SECTOR MODULE?

The FDA product code for INTEGRAL SECTOR MODULE is IYO.

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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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