← Product Code [BSZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ) · K963994 # NARKOMED GS ANESTHESIA SYSTEM (K963994) _Draeger Medical, Inc. · BSZ · Mar 19, 1997 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K963994 ## Device Facts - **Applicant:** Draeger Medical, Inc. - **Product Code:** [BSZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ.md) - **Decision Date:** Mar 19, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5160 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use The NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume. ## Device Story Narkomed GS (NMGS) is a continuous flow gas anesthesia system; provides spontaneous, manually assisted, or automatic ventilation; delivers anesthetic gases and vapors. Integrated monitors track oxygen concentration, breathing pressure, and respiratory volume. Used in clinical settings (OR) by anesthesia providers. Incorporates AV2+ anesthesia ventilator as integral subassembly. Features optional two or three vaporizer configurations. Includes serial interface (Vitalink protocol) for communication with external monitors (Vitalert 2000/3000). Supports clinical decision-making by providing real-time respiratory and gas delivery data to the clinician. ## Clinical Evidence Bench testing only. Qualification included hazard analysis, software verification, environmental testing, and electromagnetic compatibility testing. ## Technological Characteristics Continuous flow gas anesthesia system. Integrated monitors for O2, pressure, and volume. Serial interface (Vitalink protocol). Optional two or three vaporizer configurations. Software-controlled ventilation via AV2+ subassembly. ## Regulatory Identification A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide). ## Predicate Devices - Narkomed 2C Anesthesia System ([K930351](/device/K930351.md)/A) - Narkomed AV2+ Anesthesia Ventilator ([K953228](/device/K953228.md)) ## Reference Devices - Vitalert 2000 monitor - Vitalert 3000 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} K963994 MAR 19 1997 # Summary of Safety and Effectiveness Data Relating to Substantial Equivalence Proprietary Name: Narkomed GS Anesthesia System Classification Name: Gas-Machine, Anesthesia 73BSZ Device Class: Class II Manufacturer: North American Dräger 3135 Quarry Road Telford, Pennsylvania 18969 Establishment Registration Number: 2517967 Devices to which substantial equivalence is claimed: - Narkomed 2C Anesthesia System K930351/A - Narkomed AV2+ Anesthesia Ventilator K953228 ## Device Description: The NMGS is a continuous flow gas anesthesia system. ## Intended Use: The NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume. ## Substantial Equivalence: The NMGS is substantially equivalent to the Narkomed 2C (NM2C) and the AV2+ Anesthesia Ventilator (AV2+). The NMGS, like the NM2C is an anesthesia system with integrated monitors for oxygen concentration, breathing pressure and respiratory volume. The gas delivery system, absorber and scavenger of the NMGS are the same design that is used on the NM2C. The NMGS uses the AV2+ anesthesia ventilator. The AV2+ is marketed as an integral subassembly of North American Dräger anesthesia systems, including the NM2C. The NMGS like the NM2C is available with a serial interface for communication via the Vitalink serial link protocol to devices such as NAD's Vitalert 2000 and 3000 monitors. {1} The NMGS differs from the NM2C by offering an optional two vaporizer configuration of the system as well as the three vaporizer configuration. The NMGS and the NM2C have the same intended use and principal of operation and are substantially equivalent. Qualification of the NMGS included hazard analysis, software verification, and qualification testing, environmental testing, and electromagnetic compatibility testing. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K963994](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K963994) **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. 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