FDA 510(k)

RAINCOAT

K-Number: K863910 · 1986-10-20

ApplicantArtec Environmental Monitoring Division

Decision Date1986-10-20

Product CodeBZO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

RAINCOAT is the device name listed in this FDA 510(k) record. The listed applicant is Artec Environmental Monitoring Division. It received FDA 510(k) clearance on 1986-10-20 under 510(k) number K863910. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAINCOAT?

RAINCOAT is a medical device that received FDA 510(k) clearance on 1986-10-20. The listed applicant is Artec Environmental Monitoring Division. The 510(k) number is K863910.

When did RAINCOAT receive FDA 510(k) clearance?

RAINCOAT received FDA 510(k) clearance on 1986-10-20, under 510(k) number K863910.

Who is the listed applicant for RAINCOAT?

The FDA 510(k) record lists Artec Environmental Monitoring Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAINCOAT?

The FDA product code for RAINCOAT is BZO.

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Other records listing Artec Environmental Monitoring Division as applicant

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Related Devices (Code: BZO)

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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.