MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM

System, Monitoring, Perinatal

HEWLETT-PACKARD CO.

The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model 80225a Obstetrical Management System.

Pre-market Notification Details

• Device ID: K861544
• 510k Number: K861544
• Device Name: MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
• Classification: System, Monitoring, Perinatal
• Applicant: HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE
• Contact: Lenke
• Correspondent: Lenke; HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE
• Product Code: HGM
• CFR Regulation Number: 884.2740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-04-24
• Decision Date: 1986-07-18