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FDA 510(k)

Synaptive ImageDrive Pro

K-Number: K153284 · 2016-03-29

ApplicantSynaptive Medical, Inc.
Decision Date2016-03-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synaptive ImageDrive Pro is the device name listed in this FDA 510(k) record. The listed applicant is Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2016-03-29 under 510(k) number K153284. 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 Synaptive ImageDrive Pro?

Synaptive ImageDrive Pro is a medical device that received FDA 510(k) clearance on 2016-03-29. The listed applicant is Synaptive Medical, Inc.. The 510(k) number is K153284.

When did Synaptive ImageDrive Pro receive FDA 510(k) clearance?

Synaptive ImageDrive Pro received FDA 510(k) clearance on 2016-03-29, under 510(k) number K153284.

Who is the listed applicant for Synaptive ImageDrive Pro?

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

What is the FDA product code for Synaptive ImageDrive Pro?

The FDA product code for Synaptive ImageDrive Pro is LLZ.

Other records listing Synaptive Medical, Inc. as applicant

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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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