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FDA 510(k)

POLYGRAM SOFTWARE

K-Number: K946322 · 1995-07-07

ApplicantSynectics Medical, Inc.
Decision Date1995-07-07
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POLYGRAM SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Synectics Medical, Inc.. It received FDA 510(k) clearance on 1995-07-07 under 510(k) number K946322. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYGRAM SOFTWARE?

POLYGRAM SOFTWARE is a medical device that received FDA 510(k) clearance on 1995-07-07. The listed applicant is Synectics Medical, Inc.. The 510(k) number is K946322.

When did POLYGRAM SOFTWARE receive FDA 510(k) clearance?

POLYGRAM SOFTWARE received FDA 510(k) clearance on 1995-07-07, under 510(k) number K946322.

Who is the listed applicant for POLYGRAM SOFTWARE?

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

What is the FDA product code for POLYGRAM SOFTWARE?

The FDA product code for POLYGRAM SOFTWARE is BZG.

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Other records listing Synectics Medical, Inc. as applicant

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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