ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115

K971828 · Alexander Mfg. Co. · DQA · Aug 12, 1997 · Cardiovascular

Device Facts

• Record ID: K971828
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
• Applicant: Alexander Mfg. Co.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Replacement battery for Nellcor, Inc. 0810-0115 N-100 Pulse Oximeter, 510(k) Number K822909. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Device Story

Replacement battery for Nellcor N-100 Pulse Oximeter; provides electrical power to device. Used by biomedical equipment technicians in clinical environments to maintain device operation. No data processing or clinical decision-making functionality; purely a power source component.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Replacement battery pack; electrical power source; form factor designed for compatibility with Nellcor N-100 Pulse Oximeter.

Indications for Use

Indicated for use as a replacement battery for the Nellcor, Inc. N-100 Pulse Oximeter in clinical settings where the original battery requires replacement.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Nellcor, Inc. 0810-0115 N-100 Pulse Oximeter (K822909)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

AUG 1 2 1997

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

Re: K971828 Replacement Battery Part Number GL0810-0115 Requlatory Class: II (two) Product Code: 74 DQA Dated: May 1, 1997 Received: May 16, 1997

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 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 reqistration, 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 Regulation (QS) for Medical Devices: General requlation (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 obliqation 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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## Page 2 - Mr. Ken Heimendinger

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/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

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: K971828

Device Name: GL0810-0115

Indications for Use:

Replacement battery for Nellcor, Inc. 0810-0115 N-100 Pulse Oximeter, 510(k) Number K822909.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

PLEASE DO NOT WRITE BELOW THIS LINE -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Atl. A. Giall.

diovascular Respiratory 510(k) Number

Prescription Use _

OR

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