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FDA 510(k)

POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)

K-Number: K933664 · 1993-12-15

ApplicantSiemens Gammasonics, Inc.
Decision Date1993-12-15
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) 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 1993-12-15 under 510(k) number K933664. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)?

POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) is a medical device that received FDA 510(k) clearance on 1993-12-15. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K933664.

When did POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) receive FDA 510(k) clearance?

POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) received FDA 510(k) clearance on 1993-12-15, under 510(k) number K933664.

Who is the listed applicant for POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)?

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 POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)?

The FDA product code for POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) is IZI.

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Other records listing Siemens Gammasonics, Inc. as applicant

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Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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