FDA 510(k)

HOOD SPEAKING VALVE

K-Number: K897059 · 1990-03-12

Decision Date1990-03-12

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

HOOD SPEAKING VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Hood Laboratories. It received FDA 510(k) clearance on 1990-03-12 under 510(k) number K897059. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOOD SPEAKING VALVE?

HOOD SPEAKING VALVE is a medical device that received FDA 510(k) clearance on 1990-03-12. The listed applicant is Hood Laboratories. The 510(k) number is K897059.

When did HOOD SPEAKING VALVE receive FDA 510(k) clearance?

HOOD SPEAKING VALVE received FDA 510(k) clearance on 1990-03-12, under 510(k) number K897059.

Who is the listed applicant for HOOD SPEAKING VALVE?

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

What is the FDA product code for HOOD SPEAKING VALVE?

The FDA product code for HOOD SPEAKING VALVE is JOH.

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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.