(65 days)
The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.
The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile.
This document is a 510(k) clearance letter for the ORS-1000LD Leak Detection Drape. It asserts substantial equivalence to a predicate device and outlines regulatory compliance, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested table and information as these details are not present in the provided text. The letter is a regulatory approval document, not a performance study report.
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.