9 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·May 13, 2026
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·October 22, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·October 22, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·October 22, 2025
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025
Ultraview SL (UVSL) Command Module, Model 91496
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·May 10, 2023
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022