FDA 510(k)

AMERICAN PHARMASEAL HUMIDAIR CONDENSER

K-Number: K854012 · 1985-12-03

Decision Date1985-12-03

Product CodeBYD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AMERICAN PHARMASEAL HUMIDAIR CONDENSER is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1985-12-03 under 510(k) number K854012. 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 AMERICAN PHARMASEAL HUMIDAIR CONDENSER?

AMERICAN PHARMASEAL HUMIDAIR CONDENSER is a medical device that received FDA 510(k) clearance on 1985-12-03. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K854012.

When did AMERICAN PHARMASEAL HUMIDAIR CONDENSER receive FDA 510(k) clearance?

AMERICAN PHARMASEAL HUMIDAIR CONDENSER received FDA 510(k) clearance on 1985-12-03, under 510(k) number K854012.

Who is the listed applicant for AMERICAN PHARMASEAL HUMIDAIR CONDENSER?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERICAN PHARMASEAL HUMIDAIR CONDENSER?

The FDA product code for AMERICAN PHARMASEAL HUMIDAIR CONDENSER is BYD.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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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

View on FDA Database →

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