MODELS M1175A AND M1176A COMPONENT MONITORING SYST

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

HEWLETT-PACKARD CO.

The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Models M1175a And M1176a Component Monitoring Syst.

Pre-market Notification Details

• Device ID: K922058
• 510k Number: K922058
• Device Name: MODELS M1175A AND M1176A COMPONENT MONITORING SYST
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE
• Contact: Gerhard Lenke
• Correspondent: Gerhard Lenke; HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-04-22
• Decision Date: 1992-10-06