MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC

K012264 · National Custom Ent., Inc. · DPS · Oct 10, 2001 · Cardiovascular

Device Facts

• Record ID: K012264
• Device Name: MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
• Applicant: National Custom Ent., Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

Replacement battery pack for MARQUETTE MAC 8, MAC PERSONAL & MAC STRESS This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Device Story

Replacement battery pack for Marquette Mac 8, Mac Personal, and Mac Stress electrocardiograph systems; provides electrical power to host device; installed by biomedical technicians or end-users; restores operational capability of host ECG unit; maintains device functionality during clinical use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Replacement battery pack; electrical power source; designed for compatibility with Marquette Mac 8, Mac Personal, and Mac Stress systems; form factor matches original battery compartment specifications.

Indications for Use

Indicated for use as a replacement battery pack for Marquette Mac 8, Mac Personal, and Mac Stress electrocardiograph devices. Intended for use by biomedical equipment technicians or customers requiring battery replacement.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white circular logo. The logo features a stylized eagle with three wing strokes, symbolizing health and human services. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the perimeter of the circle, with the eagle positioned in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2001

Mr. Don Pelletier National Custom Enterprises, Inc. 1133 E. Cliff Rd. Burnsville, MN 55337

Re: K012264

Trade Name: Model N3043IWC replacement battery for Marquette Mac8, and Mac Stress Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: July 12, 2001 Received: July 18, 2001

Dear Mr. Pelletier:

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. Don Pelletier

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,

James F. Dillard III

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Applicant: National Custom Enterprises, Inc. [phone]

510(k) Number: _ K012264

N3043IWC Device Name:

Indications For Use: Replacement battery pack for

MARQUETTE MAC 8, MAC PERSONAL & MAC STRESS

This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Concurrence of CDRH, Office of Device Evaluation (ODE)

NoleTech
Division of Cardiology Respiratory Devices
510(k) Number K012264

Prescription Use (Per 21 CFR 801.109) OR

**Over-The-Counter Use**