FDA 510(k)

STOM-VENT

K-Number: K872153 · 1987-08-03

Decision Date1987-08-03

Product CodeBYD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

STOM-VENT is the device name listed in this FDA 510(k) record. The listed applicant is Gibeck Respiration. It received FDA 510(k) clearance on 1987-08-03 under 510(k) number K872153. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOM-VENT?

STOM-VENT is a medical device that received FDA 510(k) clearance on 1987-08-03. The listed applicant is Gibeck Respiration. The 510(k) number is K872153.

When did STOM-VENT receive FDA 510(k) clearance?

STOM-VENT received FDA 510(k) clearance on 1987-08-03, under 510(k) number K872153.

Who is the listed applicant for STOM-VENT?

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

What is the FDA product code for STOM-VENT?

The FDA product code for STOM-VENT is BYD.

Other records listing Gibeck Respiration as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881657HUMID-VENT FILTER K881656HUMID-VENT 2 S FLEX K881644HUMID-VENT 2 S K873768HUMID-VENT(R) 2 PORT K873767HUMID-VENT(R) MINI

Related Devices (Code: BYD)

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom Medical K953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor AB K953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

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.