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FDA 510(k)

REGULATOR-INHALATOR SYSTEM

K-Number: K853971 · 1985-12-09

ApplicantStephenson Industries, Inc.
Decision Date1985-12-09
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REGULATOR-INHALATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stephenson Industries, Inc.. It received FDA 510(k) clearance on 1985-12-09 under 510(k) number K853971. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGULATOR-INHALATOR SYSTEM?

REGULATOR-INHALATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Stephenson Industries, Inc.. The 510(k) number is K853971.

When did REGULATOR-INHALATOR SYSTEM receive FDA 510(k) clearance?

REGULATOR-INHALATOR SYSTEM received FDA 510(k) clearance on 1985-12-09, under 510(k) number K853971.

Who is the listed applicant for REGULATOR-INHALATOR SYSTEM?

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

What is the FDA product code for REGULATOR-INHALATOR SYSTEM?

The FDA product code for REGULATOR-INHALATOR SYSTEM is BTL.

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Other records listing Stephenson Industries, 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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