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FDA 510(k)

UNISKAN II

K-Number: K861897 · 1986-07-01

ApplicantFlow Laboratories, Inc.
Decision Date1986-07-01
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNISKAN II is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K861897. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISKAN II?

UNISKAN II is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K861897.

When did UNISKAN II receive FDA 510(k) clearance?

UNISKAN II received FDA 510(k) clearance on 1986-07-01, under 510(k) number K861897.

Who is the listed applicant for UNISKAN II?

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

What is the FDA product code for UNISKAN II?

The FDA product code for UNISKAN II is JJQ.

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Other records listing Flow Laboratories, Inc. as applicant

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Related Devices (Code: JJQ)

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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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