(88 days)
The Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or trained technician to measure lung function in patients of all ages. It can be used in any setting, home, factory, hospital or physician's office.
Not Found
This document is a 510(k) clearance letter from the FDA for the SDI Spirolab II Spirometer. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.
Therefore, I cannot answer your request based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Michael J. Boyle SDI Diagnostics, Inc. 10 Hampden Drive Easton, MA 02375
Re: K013812
SDI Spirolab II Spirometer Regulation Number: 868.1840 Regulation Name: Spirometer, Diagnostic Regulatory Class: Class II (two) Product Code: 73 BZG Dated: November 9, 2001 Received: November 15, 2001
Dear Mr. Boyle:
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.
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Page 2 - Mr. Michael J. Boyle
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc acrisou that I Dr o resum that your device complies with other requirements of the Act that I DA has made a asid regulations administered by other Federal agencies. You must of any I coloral statutes and regainments, including, but not limited to: registration and listing (21 Comply with an the 11et 31equirements) and manufacturing practice requirements as set CFN in the quality systems (DF CFR Part 820); and if applicable, the electronic form in the quality by see in orovisions (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) I mis icher will anow you to organ maing of substantial equivalence of your device to a legally prematics notineation: The PDF interessification 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 If you desire specific ad 100 for you in vitro diagnostic devices), please contact the Office of additionally 21 OFF Far 8041. Additionally, for questions on the promotion and advertising of Compliance at (301) 694-639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation circulou, Tribonananing responsibilities under the Act may be obtained from the Oiner general information 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,
Roderick Teller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SDI Diagnostics, Inc.
SDI Spirolab II Spirometer . K013812
Statement of Intended Use
The Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or The Spirolab if Spirometer is mendou to of all ages. It can be used in any setting, home, factory hospital or physician's office.
Prescription Use √
Division of Cardiovascular & Respiratory Devices
510(k) Number K013812
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).