STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER

• K Number: K955152
• Device Name: STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
• Manufacturer: STOECKERT INSTRUMENTE
• Date Cleared: 1996-02-22 ( 101 days)
• Product Code: DTW , DTQ , KRL
• Regulation Number: 870.4340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.

(a)
Identification. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.