(168 days)
The Foremount Pocket Size Resuscitator / Model M16201R is indicated for use of The Foremount Pocket oize Nesubonator Amedel with non-rebreathing valve for adult and child whose weight exceeds 10kg. The resuscitator with oxygen port is for prescription use.
The Foremount Pocket Size Resuscitator / Model M16201A is indicated for use of ter and The Foremount Pocket Size Resulsciator / Model MTF22 MTF mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult . In mask ventilation via the and child whose weight exceeds 10kg. and child whose worgen oxygen port is for over-the-counter use.
Not Found
This is a 510(k) clearance letter for a medical device, the "Pocket Size Resuscitator," and not a study report describing acceptance criteria and device performance data. Therefore, the requested information about acceptance criteria, performance tables, sample sizes, expert qualifications, and ground truth establishment is not present in the provided text.
The document primarily states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices, allowing its marketing. It outlines regulatory requirements the manufacturer must adhere to.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or a bird with three wing-like shapes.
Public Health Service
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tyson Hsu Official Correspondent Foremount Ent. Co. Ltd. 9F-4. No. 1, Lane 641, Shen-Lin South Road, Ta-va Hsiang, Taichung, TAIWAN, R.O.C.
Rc: K042727
Trade/Device Name: Pocket Size Resuscitator/Models M16201A, M16201R Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: March 2, 2005 Received: March 3, 2005
Dear Mr. Hsu:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yoursed your entermined the device is substantially equivalent (for the referenced above and 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 approvisions 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 (1 Mr), it may ob adgest 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.
{1}------------------------------------------------
Page 2 - Mr. Hsu
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 modifine and Federal statutes and regulations administered by other Federal agencies. or the For of any I outh 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 and ifsuing (2 - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as better 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), r you donto the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Qeulian for
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
Indications For Use
510(k) Number (if known):
Device Name: Pocket Size Resuscitator / Model M16201R.
Indications For Use:
The Foremount Pocket Size Resuscitator / Model M16201R is indicated for use of The Foremount Pocket oize Nesubonator Amedel with non-rebreathing valve for adult and child whose weight exceeds 10kg.
The resuscitator with oxygen port is for prescription use.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques Sylvam
Fordy JO MORE Chon Carm
{3}------------------------------------------------
Indications For Use
510(k) Number (if known):
Device Name: Pocket Size Resuscitator / Model M16201A.
Indications For Use:
The Foremount Pocket Size Resuscitator / Model M16201A is indicated for use of
ter and The Foremount Pocket Size Resulsciator / Model MTF22 MTF
mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult
. In mask ventilation via the and child whose weight exceeds 10kg. and child whose worgen oxygen port is for over-the-counter use.
Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ouer Svelson
Page 1 of __ 1 _______________________________________________________________________________________________________________________________________________________________
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).