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FDA 510(k)

SYNAPTIC 3000

K-Number: K940954 · 1997-06-20

ApplicantThe Synaptic Corp.
Decision Date1997-06-20
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNAPTIC 3000 is the device name listed in this FDA 510(k) record. The listed applicant is The Synaptic Corp.. It received FDA 510(k) clearance on 1997-06-20 under 510(k) number K940954. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNAPTIC 3000?

SYNAPTIC 3000 is a medical device that received FDA 510(k) clearance on 1997-06-20. The listed applicant is The Synaptic Corp.. The 510(k) number is K940954.

When did SYNAPTIC 3000 receive FDA 510(k) clearance?

SYNAPTIC 3000 received FDA 510(k) clearance on 1997-06-20, under 510(k) number K940954.

Who is the listed applicant for SYNAPTIC 3000?

The FDA 510(k) record lists The Synaptic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNAPTIC 3000?

The FDA product code for SYNAPTIC 3000 is GZJ.

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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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