GREENLIGHT 300

K040410 · A C Cossor & Son (Surgical) Limited · DXN · May 5, 2004 · Cardiovascular

Device Facts

• Record ID: K040410
• Device Name: GREENLIGHT 300
• Applicant: A C Cossor & Son (Surgical) Limited
• Product Code: DXN · Cardiovascular
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended to be used by medical professionals only for the measurement of systolic and diastolic blood pressure values. The device is intended to be used with blood pressure cuffs supplied for use with the device which are manually attached to a patient and individually inflated, with a range of adult, pediatric and neonate sizes in exactly the same way and substantially equivalent to the Accoson greenlight 300 sphygmomanometer under 510(k) for adult, pediatric and neonate patient groups.

Device Story

Accoson Greenlight 300 is a noninvasive sphygmomanometer; used by medical professionals in clinical settings. Device utilizes manual inflation of blood pressure cuffs; relies on manual auscultatory method for detecting Korotkoff sounds to determine systolic and diastolic blood pressure. System supports range of cuff sizes for adult, pediatric, and neonate patients. Output is visual pressure reading for clinician interpretation; assists in cardiovascular assessment and patient monitoring.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Noninvasive sphygmomanometer; manual inflation/deflation mechanism; utilizes Korotkoff sound detection via manual auscultation; compatible with various adult, pediatric, and neonate cuff sizes. Mechanical device; no software or electronic sensing components.

Indications for Use

Indicated for measurement of systolic and diastolic blood pressure in adult, pediatric, and neonate patient populations by medical professionals using manual Korotkoff sound detection.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

1. Beller Bron

A. C. Cossor & Son (Surgical) Ltd. c/o Mr. A. J. Cossor Director Accoson Works Vale Road London N4 1PS UNITED KINGDOM

Re: K040410

Trade Name: Accoson Greenlight 300 Sphygmomanometer Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurcment System Regulatory Class: II (two) Product Code: DXN Dated: February 16, 2004 Received: March 10, 2004

Dear Mr. Cossor:

Wc have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosed of to stgasy the Medical Device Amendments, or to connineres phor to may 20, 1978, as econdance with the provisions of the Federal Food, Drug, uevices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (11et) that de novice, subject to the general controls provisions of the Act. The 1 ou may, therefore, thanks the act include requirements for annual registration, listing of general econtrols proving 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 may be subject to back acceral 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. A. J. Cossor

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri a location or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any it call the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CIN I at 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only of probegin marketing your device as described in your Section 510(k) This icuer with anow you to begin maxioning of substantial equivalence of your device to a legally prematication: "The PDF intemsgssification 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), please If you desire spoonte aarros 70- 9 1) 594-4648. Also, please note the regulation entifled, Connect the Office of Court to premarket notification" (21CFR Part 807.97). You may obtain of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Arlene B. Boane

Bra
Di
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Ko40410

Device Name:_Accoson_greenlight 300 sphygmomanometer

Indications For Use:

The device is intended to be used by medical professionals only for the measurement of The device is intended to be used by moules. The device is intended to be used with attesped to a systolic and diastolic blood pressure valuer related which are manually attached to a
blood pressure cuffs supplied for use with the device Kerefleff overde biood pressure curis Supplied for ass with a manual method for detecting Koroticoline in exactly patient and inalidally innated, with a range of adult, pediatric and neonate sizes in exactly The device currs are available in a range of a and, or sale in the United States. the Same Way and Substantally oqurvation the Accoson greenlight 300 sphygmomanometer under 370(it) humr adult, pediatric and neonate patient groups.

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/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)

Ashley B. Brown

(Division Sign Off Division of Cardiovascular Devices

510(k) Number_

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