← Product Code [HGM](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGM) · K964770 # COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR (K964770) _Ge Medical Systems Information Technologies · HGM · Feb 21, 1997 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGM/K964770 ## Device Facts - **Applicant:** Ge Medical Systems Information Technologies - **Product Code:** [HGM](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGM.md) - **Decision Date:** Feb 21, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.2740 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment. ## Device Story 120 Series Maternal/Fetal Monitor; monitors fetal heart rate (FHR), uterine activity (UA), maternal heart/pulse rate, non-invasive blood pressure (NBP), and %SpO2. Adds maternal ECG (MECG) waveform monitoring capability compared to predicate Model 118. Used in hospital/clinical environments by healthcare professionals. Device processes physiological signals to provide real-time vital sign data for clinical assessment of maternal and fetal status. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Class II maternal/fetal monitor. Modalities: FHR, UA, maternal heart/pulse rate, NBP, %SpO2, MECG waveform. Standalone clinical monitor. No specific materials or software architecture details provided. ## Regulatory Identification A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts. ## Predicate Devices - Model 118 Maternal/Fetal Monitor ([K934959](/device/K934959.md)) - Model 556 Critical Care Monitor ([K911310](/device/K911310.md)) ## 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} K964770 p1/2 Corometrics Medical Systems, Inc. 120 Series 510(k) Premarket Notification Submission November 1996 # 9.0 510(k) SUMMARY: Corometrics 120 Series FEB 21 1997 Prepared: 26 November 1996 ## [807.92(a)1] Contact Information Maria Vitug Fouts Sr. Regulatory Compliance Specialist Address: Corometrics Medical Systems, Inc. 61 Barnes Park Road North Wallingford, CT 06492 Phone: 203-949-2538 Fax: 203-284-9465 ## [807.92(a)2] Device Name and Classification The proprietary name of the modified device to be introduced into interstate commerce is the 120 Series Maternal/Fetal Monitor. Common names include: 120 Series, 120 MFM. As with the predicate Model 118, the 120 Series is a Class II device. ## [807.92(a)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems). | Predicate System | Manufacturer | k Number | | --- | --- | --- | | Model 118 Maternal/Fetal Monitor | Corometrics Medical Systems, Inc. 61 Barnes Park Road North Wallingford, CT 06492 | k934959, clearance date: 10/15/94 | | Model 556 Critical Care Monitor | | k911310, clearance date: 6/10/91 | ## [807.92(a)4 & 807.92(a)5] Device Description & Intended Use The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment. ## [807.92(a)6] Predicate Device Comparison of Technological Characteristics | Monitoring Mode | 120 Series | Model 118 | Model 556 | | --- | --- | --- | --- | | FHR/UA Monitoring | Yes | Yes | Not Applicable | | Maternal Heart/Pulse Rate, NBP, Sp02 Monitoring | Yes | Yes | | | MECG Waveform | Yes | No | Yes | {1} Corometrics Medical Systems, Inc. 120 Series 510(k) Premarket Notification Submission K964770 P2/2 November 1996 [807.92(b)1, 807.92(b)2 & 807.92(b)3] Performance Standards per the Food, Drug and Cosmetic Act To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration. [807.92(d)] Additional Information The 120 Series has been extensively tested to meet its requirements and design. Page 419 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGM/K964770](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGM/K964770) **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