MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)

Oximeter

HEWLETT-PACKARD CO.

The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model 78834c Neonatal Pulse Oximeter (sao2).

Pre-market Notification Details

• Device ID: K901819
• 510k Number: K901819
• Device Name: MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
• Classification: Oximeter
• 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: DQA
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-04-23
• Decision Date: 1990-07-18