NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)

System, Measurement, Blood-pressure, Non-invasive

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Non-invasive Blood Pressure (nibp) Monitor (model 90553).

Pre-market Notification Details

• Device ID: K941167
• 510k Number: K941167
• Device Name: NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713
• Contact: Russ Garrison
• Correspondent: Russ Garrison; SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-14
• Decision Date: 1994-11-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B468LC300WC0	K941167	000
B468LC300	K941167	000