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FDA 510(k)

DIGITRON STENOSIS PROTOCOL

K-Number: K881481 · 1988-10-12

ApplicantSiemens Gammasonics, Inc.
Decision Date1988-10-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITRON STENOSIS PROTOCOL 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 1988-10-12 under 510(k) number K881481. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITRON STENOSIS PROTOCOL?

DIGITRON STENOSIS PROTOCOL is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K881481.

When did DIGITRON STENOSIS PROTOCOL receive FDA 510(k) clearance?

DIGITRON STENOSIS PROTOCOL received FDA 510(k) clearance on 1988-10-12, under 510(k) number K881481.

Who is the listed applicant for DIGITRON STENOSIS PROTOCOL?

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 DIGITRON STENOSIS PROTOCOL?

The FDA product code for DIGITRON STENOSIS PROTOCOL is LLZ.

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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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