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FDA 510(k)

BACT-HME (TM)

K-Number: K903058 · 1990-11-09

ApplicantPharma Systems, Inc.
Decision Date1990-11-09
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BACT-HME (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Pharma Systems, Inc.. It received FDA 510(k) clearance on 1990-11-09 under 510(k) number K903058. 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 BACT-HME (TM)?

BACT-HME (TM) is a medical device that received FDA 510(k) clearance on 1990-11-09. The listed applicant is Pharma Systems, Inc.. The 510(k) number is K903058.

When did BACT-HME (TM) receive FDA 510(k) clearance?

BACT-HME (TM) received FDA 510(k) clearance on 1990-11-09, under 510(k) number K903058.

Who is the listed applicant for BACT-HME (TM)?

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

What is the FDA product code for BACT-HME (TM)?

The FDA product code for BACT-HME (TM) is BYD.

Other records listing Pharma Systems, Inc. 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.

K903057FREEVENT (TM)K903055EXTENDED LIFE CIRCUITSK903056BACTTRAPK903054HME-10 (TM)

Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-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.

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