← Product Code [BSZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ) · K946127 # OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM (K946127) _Ohmeda Medical · BSZ · Oct 8, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K946127 ## Device Facts - **Applicant:** Ohmeda Medical - **Product Code:** [BSZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ.md) - **Decision Date:** Oct 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5160 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use The Ohmeda Excel Draw-Over Military Vaporizer System is specifically designed for use with the Ohmeda Single-Agent Draw-Over Vaporizer. It consists of an Excel 210 system with an attached draw-over vaporizer. The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply. ## Device Story System provides platform for inhalation anesthetic delivery; utilizes Ohmeda Excel 210 base modified with kit for Ohmeda Single-Agent Draw-Over Vaporizer. Kit includes mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, and extended oxygen enrichment tube. Operated by clinicians in military environments. Device facilitates draw-over anesthesia technique; allows supplemental gas supply. Benefits include portable, adaptable anesthesia delivery in field or specialized military contexts. ## Clinical Evidence Bench testing only. Compliance with ASTM F1161-1988 and MIL-STD-1472B standards documented. ## Technological Characteristics Anesthesia delivery system; includes draw-over vaporizer, mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, oxygen enrichment tube. Complies with ASTM F1161-1988 and MIL-STD-1472B. Mechanical/pneumatic operation; no software or electronic sensing/actuation described. ## 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 - Ohmeda 'B' Series Gas Delivery System ([K863207](/device/K863207.md)) - Ohmeda PAC Portable Anesthesia Machine (K850648A) - Ohmeda Universal PAC Portable Anesthesia Machine (K901117A) ## 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} FROM : 15:12 434 0.24/05 # OHMEDA K946127 OFF THE BOC GROUP Ohmeda Inc Ohmeda Drive PO Box 7550 Madison WI 53707-7550 608 221 1551 October 2, 1996 Subject: 510(k) Summary of Safety and Effectiveness Information for the Ohmeda Excel Draw-Over Military Vaporizer System Proprietary: Ohmeda Excel Draw-Over Military Vaporizer System Common: Anesthesia Machine Classification: Primary: Gas Machine for Anesthesia Class II 21CFR868.5160 - 73BSZ Secondary: Anesthetic Vaporizer (non heated) Class II 21CFR868.5880 - 73CAD Breathing Gas Mixer Class II 21CFR868.5330 - 73BZR Uncompensated Thorpe Tube Flowmeter Class II 21CFR868.2320 - 73CCN This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992. The Ohmeda Excel Draw-Over Military Vaporizer System is substantially equivalent to the following currently marketed Ohmeda devices: 1. Ohmeda 'B' Series Gas Delivery System (currently known as the Ohmeda Excel Anesthesia System) which was the subject of a cleared 510(k) premarket notification on 10/30/86 with FDA log number K863207. 2. Ohmeda PAC Portable Anesthesia Machine that was the subject of a cleared 510(k) premarket notification on 7/1/85 with FDA log number K850648A. 3. Ohmeda Universal PAC Portable Anesthesia Machine that was the subject of a cleared 510(k) premarket notification on 9/7/90 with FDA log number K901117A. The Ohmeda Excel Draw-Over Military Vaporizer System is specifically designed for use with the Ohmeda Single-Agent Draw-Over Vaporizer. It consists of an Excel 210 system with an attached draw-over vaporizer. The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply. The Ohmeda Excel Draw-Over Military Vaporizer System is a modification of the Ohmeda Excel 210 that has been made to facilitate the Ohmeda Single-Agent Draw-Over Vaporizer and the militaries needs. The system consists of an Ohmeda Single Agent Draw Over Vaporizer and a kit that allows the vaporizer to be used with an Ohmeda Excel system. The kit consists of mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, and an extended length oxygen enrichment tube. The Ohmeda Excel Draw-Over Military Vaporizer System was designed to comply with the applicable portions of the following voluntary standards: 1. ASTM F1161-1988 - "Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Continuous Flow Anesthesia Machines". 2. MIL-STD-1472B - "Human Engineering Design Criteria for Military Systems, Equipment and Facilities". Standards agencies, such as U.L. and E.T.L., do not provide specific certification services for this type of device. The Ohmeda Excel Draw-Over Military Vaporizer System and the currently marketed devices are substantially equivalent in technological characteristics, theory of operation, and use of accessories. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K946127](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K946127) **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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