ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212

K972084 · Alexander Mfg. Co. · FLN · Jul 3, 1997 · General Hospital

Device Facts

• Record ID: K972084
• Device Name: ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
• Applicant: Alexander Mfg. Co.
• Product Code: FLN · General Hospital
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2420
• Device Class: Class 2

Intended Use

Replacement battery for Timeter 41B905FD19G1 KHM2000 Drip Watcher Monitor Insert, 510(k) Number K844556. 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

Device is a rechargeable replacement battery (M212) for the Timeter 41B905FD19G1 KHM2000 Drip Watcher Monitor. It serves as a power source replacement for the specified medical monitor. Distributed to biomedical equipment technicians for maintenance and repair of existing clinical equipment. No active processing, sensing, or software components; functions as a passive electrical power storage unit.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rechargeable battery. Form factor and electrical specifications designed for compatibility with Timeter 41B905FD19G1 KHM2000 Drip Watcher Monitor. No software, sensing, or active electronic processing.

Indications for Use

Indicated for use as a replacement battery for the Timeter 41B905FD19G1 KHM2000 Drip Watcher Monitor Insert. Intended for use by biomedical equipment technicians.

Regulatory Classification

Identification

An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.

Predicate Devices

• Timeter 41B905FD19G1 KHM2000 Drip Watcher Monitor Insert (K844556)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the three branches of government.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 1997

Mr. Ken Heimendinger Alexander Manufacturing Company 1511 South Garfield Place· Mason City, Iowa 50401

Re : K972084 Alexander Manufacturing Company Rechargeable Trade Name: Battery Part Number M212 Requlatory Class: II Product Code: FLN Dated: May 30, 1997 Received: June 4, 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the ourrent Good Manufacturing Practice requirement, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Heimendinger

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in yitro 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.fpa.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K97 Zdýy

Device Name: * M212

Indications for Use:

Replacement battery for Timeter 41B905FD19G1 KHM2000 Drip Watcher Monitor Insert, 510(k) Number K844556.

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.

- (Division Sign-Off) *Matex Crucenite*
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number *K972084*

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use