MIE FALCON, DATEX ENGSTROM FLEXIMA II

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 12 1997 Mr. Henry Marshall Medical Industrial Equipment Limited Falcon Road Sowton Industrial Estate EX2 7NA ENGLAND Re: K971030 Falcon Anesthesia System and Flexima II Anesthesia System Regulatory Class: II (two) Product Code: 73 BSZ Dated: August 12, 1997 Received: August 20, 1997 Dear Mr. Marshall: 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 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, 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 Drug 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 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 regulations. {1} Page 2 - Mr. Henry Marshall 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 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 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours,  Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Page 1 of 1 510(k) Number (if known): K 971030 Device Name: MIE Falcon Anaesthesia Machine fitted with the Kestrel Anaesthesia Ventilator Datex Flexima II Anaesthesia Machine fitted with the Flexivent II Anaesthesia Ventilator Indications For Use: These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, Enflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments. (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 Neurological Devices 510(k) Number Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)