HEWLETT-PACKARD MODEL M1351A FETAL MONITOR

System, Monitoring, Perinatal

HEWLETT-PACKARD CO.

The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Model M1351a Fetal Monitor.

Pre-market Notification Details

• Device ID: K921957
• 510k Number: K921957
• Device Name: HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
• Classification: System, Monitoring, Perinatal
• Applicant: HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE
• Contact: Erich Courtin
• Correspondent: Erich Courtin; HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE
• Product Code: HGM
• Subsequent Product Code: HEL
• Subsequent Product Code: HFM
• CFR Regulation Number: 884.2740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-04-27
• Decision Date: 1993-09-24