MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP

K974682 · Biological Controls, Inc. · FRF · Jan 23, 1998 · General Hospital

Device Facts

• Record ID: K974682
• Device Name: MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
• Applicant: Biological Controls, Inc.
• Product Code: FRF · General Hospital
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

Device Story

The Microcon air purifier series (800M, 400M, Ex, ExC, Wall-Map) functions as an air filtration system designed to remove airborne particles from medical environments. The device operates by drawing in ambient air, passing it through internal filtration media to capture particulate matter, and exhausting filtered air back into the environment. It is intended for use in healthcare facilities to improve air quality. The device is operated by healthcare staff or facility personnel. By reducing airborne particle concentrations, the system aims to assist in maintaining a cleaner clinical environment, potentially reducing the risk of exposure to airborne contaminants for patients and staff.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air filtration system utilizing mechanical filtration media to capture airborne particles. Form factors include portable units (800M, 400M, Ex, ExC) and wall-mounted configurations (Wall-Map).

Indications for Use

Indicated for filtering airborne particles from air for medical purposes in clinical or healthcare settings.

Regulatory Classification

Identification

A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is composed of three intertwined strands, representing health, services, and human concerns.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 1998

Mr. Gary D. Messina President Biological Controls, Incorporated One Industrial Way West Building E, Unit M Eatontown, New Jersey 07724

Re : K974682 Trade Name: Microcon 800M, 400M, Ex, ExC and Wall-Map Air Purifier Requlatory Class: II Product Code: FRF Dated: December 10, 1997 Received: December 15, 1997

Dear Mr. Messina:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Messina

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number (if krown):

Device Name: _ MICROCON MAP-800M Air Purifier; MICROCON MAP-400M Air Purifier; MICROCC WallMAP Air Purifier; MICROCON EX Air Purifier and MICROCON EXC Air Puri Indications For Usc:

The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

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Concertionce of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)

Division of Dental, Infection Control, and General Hospital I 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)