FDA 510(k)

NASOGASTRIC VOICETUBE

K-Number: K871632 · 1987-09-16

Decision Date1987-09-16

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

NASOGASTRIC VOICETUBE is the device name listed in this FDA 510(k) record. The listed applicant is American Omni Medical, Inc.. It received FDA 510(k) clearance on 1987-09-16 under 510(k) number K871632. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASOGASTRIC VOICETUBE?

NASOGASTRIC VOICETUBE is a medical device that received FDA 510(k) clearance on 1987-09-16. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K871632.

When did NASOGASTRIC VOICETUBE receive FDA 510(k) clearance?

NASOGASTRIC VOICETUBE received FDA 510(k) clearance on 1987-09-16, under 510(k) number K871632.

Who is the listed applicant for NASOGASTRIC VOICETUBE?

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

What is the FDA product code for NASOGASTRIC VOICETUBE?

The FDA product code for NASOGASTRIC VOICETUBE is BTR.

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Related Devices (Code: BTR)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.