OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that also suggest human profiles. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUL 3 0 2002 OEMedic International, Incorporated C/O Mr. Kevin Walls Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127 Re: K021442 Trade/Device: Besmed® Single Use Manual Resuscitator Regulation Number: 868.5915 Regulation Name: Emergency manual resuscitator Regulatory Class: II Product Code: BTM Dated: May 3, 2002 Received: May 6, 2002 Dear Mr. Walls: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA). 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {1}------------------------------------------------ ## Page 2 - Mr. Kevin Walls, RAC You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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, Timothy A. Ulatowski Timo A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | | Page 1 of 1 | |---------------------------|-------------| | 510(k) Number (if known): | K021442 | OEMedic International Inc. Besmed® Single Use Adult Manual Device Names: Resuscitator with Mask and Reservoir OEMedic International Inc. Besmed® Single Use Child Manual Resuscitator with Mask and Reservoir OEMedic International Inc. Besmed® Single Use Infant Manual Resuscitator with Mask and Reservoir Indications for Use: The OEMedic International Inc. Besmed® Single Use Manual Resuscitators are indicated to temporarily augment ventilation in patients. PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign Off Division of Cardiovascular, Respiratory and DAGIT Neurological Devices 510(k) Number K021442 | <strong>Labels</strong> | <strong>Values</strong> | |-------------------------|-------------------------| | Prescription Use | X | | OR | | | Over-The-Counter Use | | Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)