PATIENT MONITOR MODEL 405P

K955546 · Ivy Biomedical Systems, Inc. · DPS · Aug 16, 1996 · Cardiovascular

Device Facts

• Record ID: K955546
• Device Name: PATIENT MONITOR MODEL 405P
• Applicant: Ivy Biomedical Systems, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Models 405T and 405P are both intended for use in Emergency Room, Surgery, Recovery Room, Intensive Care and surgical applications.

Device Story

Model 405P physiological monitor; inputs include ECG, heart rate, pulse oximetry, and non-invasive blood pressure signals. Device processes physiological data to display real-time patient status. Used in emergency rooms, surgery, recovery rooms, and intensive care units by clinicians. Output provided via LCD and LED numeric displays. Facilitates patient monitoring and clinical decision-making by providing continuous vital sign data.

Clinical Evidence

No clinical data provided; substantial equivalence based on functional comparison to predicate device.

Technological Characteristics

Patient monitor; LCD and LED numeric display; parameters: ECG, heart rate, pulse oximetry, non-invasive blood pressure. Replaces previous electroluminescent display technology.

Indications for Use

Indicated for adult or neonate patient monitoring of ECG, Heart Rate, Pulse Oximetry, and Non-Invasive Blood Pressure in clinical settings including Emergency Room, Surgery, Recovery Room, and Intensive Care.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Ivy Biomedical Systems Model 405T physiological monitor

Submission Summary (Full Text)

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AUG 16 1996
K955340
IVY
IVY BIOMEDICAL SYSTEMS, INC.
# 510(K) SUMMARY

Ivy Biomedical Systems, Inc.
11 Business Park Drive
Branford, CT 06405
[phone]
Contact: Dick Listro
Prepared: 10/12/95

Classification Name: Patient Monitor
Common Name: Patient Monitor
Proprietary Name: Model 405P

This Summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807-92.

## Substantial Equivalence

The Model 405P physiological monitor is the same in function and operation as the F.D.A. approved Ivy Biomedical Systems Model 405T physiological monitor, with the following exceptions:

- The replacement of the flat panel electrolumiesent display with a Liquid Crystal Display and LED’s for numerics
- The deletion of the option to monitor Temperature.
- The deletion of the option to monitor invasive blood pressure.

These exceptions have no adverse effect on the safety or effectiveness of the device when used as labeled.

The Models 405T and 405P patient monitors are both adult or neonate monitors

The 405P monitors the following parameters:
ECG, Heart Rate, Pulse Oximetry and Non-Invasive Blood Pressure.

The Models 405T and 405P are both intended for use in Emergency Room, Surgery, Recovery Room, Intensive Care and surgical applications.

Signature
*Richard Listo*
Date
11/31/95

510ksum.doc
Section 2

11 Business Park Drive, Branford, Connecticut 06405 • [phone] [phone] FAX: [phone]