SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC

• K Number: K012229
• Device Name: SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
• Manufacturer: NATIONAL CUSTOM ENT., INC.
• Date Cleared: 2001-09-10 ( 56 days)
• Product Code: FMT
• Regulation Number: 880.5130
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

Replacement battery pack for SCALE-TRONIX MODEL 48, 2001, 2009, 2700, 3003, 4004, 4800, 5005, 5700, 6006, 6500, 6700, 6006C & 20009 SCALES

Device Description

Replacement battery pack

AI/ML Overview

Unfortunately, this document is a 510(k) premarket notification letter from the FDA regarding a replacement battery pack for medical scales.

It does not contain any information about acceptance criteria, device performance during a study, or the details of any clinical or performance studies. The letter primarily focuses on the FDA's "substantial equivalence" determination to a legally marketed predicate device, allowing the manufacturer to market the product.

Therefore, I cannot provide the requested information from this document. I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification, to answer your questions thoroughly.

Regulation Number and Section

§ 880.5130 Infant radiant warmer.

(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.