(163 days)
The Golemb Disposable Bag Mast Resuscitator is a single patient use system for manual resuscitation.
Not Found
The provided text is a 510(k) premarket notification approval letter for the "Golemb Disposable Bag Mask Resuscitator." This document is a regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA approval stating the device is substantially equivalent to a predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JA 2 9 1998
Mr. Vernon Trimble Allied Healthcare Products, Inc. 1720 Sublette Avenue St. Louis, MO 63110
Re: K973106 Golemb Disposable Bag Mask Resuscitator Regulatory Class: II (two) 73 BTM Product Code: December 2, 1997 Dated: December 9, 1997 Received:
Dear Mr. Trimble:
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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.
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Page 2 - Mr. Vernon Trimble
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
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
510(k) Number (if known): K973/06
Solemp Dispasak Bag Mask Device Name:
Indications For Use:
Application for the Product
The Golemb Disposable Bag Mast Resuscitator is a single patient use system for manual resuscitation.
Population
The Golemb Disposable Bag Mast Resuscitator is designed to be used for adults, pediatrics, and infants.
Environment for use
The primary intended use for the product is in the Emergency Medical Service(EMS) Industry; however, the product can be used when manual resuscitation is required.
Revised 11/12/97
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Cardiovascular, R and Neurological Devices K973100 510(k) Number . Prescription Use v Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ રીકે (Per 21 CFR 801.109) (Optional Format 1-2-96)
iGriginal Format 1-2-46
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).