(231 days)
When used with Hudson RCI CONCHATHERM heaters and Hudson RCI ventilator circuits, the 385-40 While Column provides heated humidification for patients with and without an artificial airway in place.
When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neouatal ventilation.
Not Found
The provided text is an FDA 510(k) clearance letter for the Hudson Respiratory Care, Inc. HRCI Cat. No. 385-40 Column and HRCI Cat. No. 780-40, 780-41, 780-42, 780-43 Circuit. This document determines substantial equivalence to legally marketed predicate devices, but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the given input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.
Public Health Service
MAY 2 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Charles Mierkiewicz Regulatory Affairs Specialist Hudson Respiratory Care, Inc. 27711 Diaz Rd. Temecula, CA 92589-9020
кадзаге Re: R33555 lason Rei Golfona Oblami, 1780-42, 780-43 Circuit Regulatory Class: II (two) 73 BTT Product Code: February 21, 2000 Dated: February 24, 2000 Received:
Dear Mr. Mierkiewicz:
We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is che device foreivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in entrosure, co regarif marico 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 the general controls provisions of the Act. 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 A substantially equivalent determination assumes compliance to 895. 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.
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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/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard İII Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if Known):
Device Name: HRCI Cat. No. 385-40 Column (trade name to be determined)/ HRCI Cat. No. 780-40, 780-41, 780-42, 780-43 Circuit (trade name to be determined)
Indications for Use (Column):
When used with Hudson RCI CONCHATHERM heaters and Hudson RCI ventilator circuits, the 385-40 While Column provides heated humidification for patients with and without an artificial airway in place.
Indications for Use (Circuit):
When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neouatal ventilation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christy foreman
K993355
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | 993355 |
|---|---|
| --------------- | -------- |
| Prescription Use | OR | Over-the-Counter Use | ||
|---|---|---|---|---|
| Per 21 CFR 801.109 |
(Optional format 1-2-96)
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§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).