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FDA 510(k)

FOAM HELMET - USE W/ESOPHAGEAL TAMPONA

K-Number: K832859 · 1983-11-14

ApplicantInmed Corp.
Decision Date1983-11-14
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOAM HELMET - USE W/ESOPHAGEAL TAMPONA is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Corp.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K832859. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOAM HELMET - USE W/ESOPHAGEAL TAMPONA?

FOAM HELMET - USE W/ESOPHAGEAL TAMPONA is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Inmed Corp.. The 510(k) number is K832859.

When did FOAM HELMET - USE W/ESOPHAGEAL TAMPONA receive FDA 510(k) clearance?

FOAM HELMET - USE W/ESOPHAGEAL TAMPONA received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832859.

Who is the listed applicant for FOAM HELMET - USE W/ESOPHAGEAL TAMPONA?

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

What is the FDA product code for FOAM HELMET - USE W/ESOPHAGEAL TAMPONA?

The FDA product code for FOAM HELMET - USE W/ESOPHAGEAL TAMPONA is KNT.

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Other records listing Inmed Corp. as applicant

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Related Devices (Code: KNT)

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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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