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FDA 510(k)

FLOCARE

K-Number: K893875 · 1989-08-11

ApplicantMega-Tech Intl., Inc.
Decision Date1989-08-11
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLOCARE is the device name listed in this FDA 510(k) record. The listed applicant is Mega-Tech Intl., Inc.. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K893875. 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 FLOCARE?

FLOCARE is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Mega-Tech Intl., Inc.. The 510(k) number is K893875.

When did FLOCARE receive FDA 510(k) clearance?

FLOCARE received FDA 510(k) clearance on 1989-08-11, under 510(k) number K893875.

Who is the listed applicant for FLOCARE?

The FDA 510(k) record lists Mega-Tech Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOCARE?

The FDA product code for FLOCARE is BYD.

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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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