AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 8 2001 Mr. James A. Cochie Monaghan Medical Corporation 5 Latour Avenue, Suite 1600 P.O. Box 2805 Plattsburgh, NY 12901-0299 Re: K012939 AeroVent IITM CHC Collapsible Holding Chamber Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II (two) Product Code: 73 CAF Dated: August 28, 2001 Received: August 31, 2001 Dear Mr. Cochie: We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars from Medical Device Amendments, or to conninered phor to May 20, 2011 accordance with the provisions of the Federal Food, Drug, de vices mat nave been receasined in asse e approval of a premarket approval application (PMA). and Costicule Hor (110.) that to novice, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controll pro restice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 as corrols. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc acvised that I Drivision that your device complies with other requirements of the Act {1}------------------------------------------------ or any Federal statutes and regulations administered by other Federal agencies. You must li or any Federal statutes and regulations administered by engistration and listing (21 l comply with all the Act's requirements, including, but not limited to: registration and comply with all the Act Stequirements, mercesses cannons onectice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing as also destron CFK Part 807); labeling (21 CFR Part 800); government 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and if any 1000 forth in the quality systems (QD) regalentin (Sections 531-542 of the Act); 21 CFR 1000-1050. Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000- This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manxemily of substantial equivalence of your device to a legally premarket nothleation. The FDA mailing of easification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and If you desire specific advice for your dovice of our the diagnostic devices), please contact the Office of additionally 21 CFK Patt 807.10 for m +120 the stimes on the promotion and advertising of Compliance at (301) 594-4646. Additionally, for questions on the promotion and abe Compliance at (301) 594-4040. Additionally, to: quested (301) 594-4639. Also, please note the your device, prease connate the Office except to premarket notification' (21CFR Part 807.97). regulation entitled, "Misbranding by reference to premarket notifical from the regulation entitled, "Misolanding by reference to printer the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Oelle Tleh James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 1 of 1 __ KO1Z939 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: Collapsible Holding Chamber used as an accessory to administer meter dose Oollapsible Trolung "Onatients being mechanically ventilated. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Division of Cardiovascular & Respiratory Devices | | |--------------------------------------------------|---------| | 510(k) Number | K012939 | | Prescription Use (Per 21 CFR 801.109) | <span style="text-decoration: underline;">✓</span> | |---------------------------------------|----------------------------------------------------| |---------------------------------------|----------------------------------------------------| or | Over-The-Counter Use | | |----------------------|--| |----------------------|--|