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The Tablo® Hemodialysis System and TabloCart™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

The Tablo® Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home. The Tablo Hemodialysis System consists of: Tablo Console and Software, Tablo Cartridge. The TabloCart™ is an optional accessory to the Tablo Hemodialysis System that raises the height of the Tablo console and includes larger wheels that rotate and lock in more functional directions than the Tablo console without a cart, aiding in overall system mobility. When configured with a Prefiltration Drawer, the cart has replaceable, large-capacity cartridge filters (sediment and/or carbon) that serve as "prefilters" to help remove major sediment and chlorine/chloramines from supply water before it enters the Tablo console's water purification system. The cart with prefiltration also includes backflow prevention and a booster pump to transport water from the incoming water supply to the Tablo console. The TabloCart with Prefiltration Drawer consists of: Tablo Cart Wheeled Platform, Fluidics Drawer and Software.

The Tablo® Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home. The Tablo Hemodialysis System consist of: 1. Tablo Console 2. Tablo Cartridge

The Tablo® Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home. The Tablo Hemodialysis System consist of: 1. Tablo Console 2. Tablo Cartridge

The Tablo® Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the Tablo Hemodialysis System is also indicated for use in the home.

The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute or chronic care facility or in the home. The device includes the: - Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and - Table Cartridge

The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.

The Tablo Cartridge is a single use blood tubing set attached to an organizer tray. The E-beam sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment.

The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the Tablo Hemodialysis System is also indicated for use in the home.

The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute or chronic care facility. This premarket notification is an indication expansion to include home use of the device. The product described in this submission includes: - . Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and - . The following accessories/components - Tablo Script (optional accessory software) o - Tablo Straws O - O Outset Acid Concentrate 1K, 2K and 3K - Outset Bicarbonate Concentrate O - Patient USB Stick O - Hand Crank O - O Locking Power Cord - Drain Line O - O Water Line - Disinfectant Straw O

The Tablo® Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, with a trained individual available as needed who is considered competent in the use of the prescribing physician. The Tablo® Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.

The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute or chronic care facility. The system's innovative design includes the: - . Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and - Tablo Cartridge, a single use blood tubing set attached to an organizer tray. The ethylene oxide (EO) sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment (Figure 1). - . Tablo Script, an accessory software to the Tablo Console, is designed for use by medical professionals to a) prepare, update and verify patient dialysis prescriptions b) view and export dialysis treatment information and billing activities and c) set and modify Tablo Console settings. Note: Tablo Script is optional, patient prescriptions can still be created or changed directly on the Tablo Console.

The Tablo™ System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, with a trained individual available as needed who is considered competent in the use of the prescribing physician.

The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. The console consists of fluidic systems that perform the activities of a Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS). Since the original 510(k) clearance, the Tablo Console has incorporated design and corresponding labeling updates whose purpose was to improve ease of manufacturing, increase reliability, simplify the design, and optimize performance.

The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, with a trained individual available as needed who is considered competent in the use of the device by the prescribing physician.

The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. The console consists of fluidic systems that perform the activities of a Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS).