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FDA 510(k)

SKYTRON MODEL 610-2

K-Number: K870045 · 1987-02-04

ApplicantSkytron, Div. the Kmw Group, Inc.
Decision Date1987-02-04
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SKYTRON MODEL 610-2 is the device name listed in this FDA 510(k) record. The listed applicant is Skytron, Div. the Kmw Group, Inc.. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K870045. The device is classified under product code INX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKYTRON MODEL 610-2?

SKYTRON MODEL 610-2 is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Skytron, Div. the Kmw Group, Inc.. The 510(k) number is K870045.

When did SKYTRON MODEL 610-2 receive FDA 510(k) clearance?

SKYTRON MODEL 610-2 received FDA 510(k) clearance on 1987-02-04, under 510(k) number K870045.

Who is the listed applicant for SKYTRON MODEL 610-2?

The FDA 510(k) record lists Skytron, Div. the Kmw Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKYTRON MODEL 610-2?

The FDA product code for SKYTRON MODEL 610-2 is INX.

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Other records listing Skytron, Div. the Kmw Group, 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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