← Product Code [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS) · K955546 # PATIENT MONITOR MODEL 405P (K955546) _Ivy Biomedical Systems, Inc. · DPS · Aug 16, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K955546 ## Device Facts - **Applicant:** Ivy Biomedical Systems, Inc. - **Product Code:** [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS.md) - **Decision Date:** Aug 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2340 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} AUG 16 1996 K955340 IVY IVY BIOMEDICAL SYSTEMS, INC. # 510(K) SUMMARY Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 (203) 481-4183 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 • (203)481-4183 (800)247-4614 FAX: (203)481-8734 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K955546](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K955546) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com