ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134

K981728 · Alexander Mfg. Co. · BZQ · Jun 26, 1998 · Anesthesiology

Device Facts

• Record ID: K981728
• Device Name: ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
• Applicant: Alexander Mfg. Co.
• Product Code: BZQ · Anesthesiology
• Decision Date: Jun 26, 1998
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

Replacement battery for Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor, 510(K) Number K862462. This battery is shipped only to customers who request a replacement battery for a particular device or to This battery is shipped only to Gatterners who we specifican therefore knows the intended use is as a replacement battery.

Device Story

Replacement battery for Nihon Kohden LifeScope 6 Portable Patient Monitor; provides electrical power to host device; used in clinical settings where monitor is deployed; operated by healthcare personnel; ensures continuous operation of patient monitoring equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Replacement battery pack; electrical energy storage; form factor designed for compatibility with Nihon Kohden LifeScope 6.

Indications for Use

Indicated for use as a replacement battery for the Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor (K862462).

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

• Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor (K862462)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 1998

Mr. Ken Heimendinger Alexander Manufacturing Company P.O. Box 1508 1511 S. Garfield Place Mason City, IA 50401

K981728 Re: Replacement Battery Part Number H134 Requlatory Class: II (two) Product Code: 73 BZQ May 12, 1998 Dated: Received: May 15, 1998

Dear Mr. Heimendinger:

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 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). 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 (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 Requlation (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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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 [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"(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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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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510(k) Number:

Device Name: H134

Indications for Use:

Replacement battery for Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor, 510(K) Number K862462.

This battery is shipped only to customers who request a replacement battery for a particular device or to This battery is shipped only to Gatterners who we specifican therefore knows the intended use is as a replacement battery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Marle Keane

(Division Sign-Off Division of Cardiovascular, Re and Neurological Device 510(k) Number

Prescription Use _

OR

OVER-THE-COUNTER USE
(optional Form 1-2-96) ✓