Review Panel：Anesthesiology Submission Type：510(k) Device Class：II Product Code：BSE Device：Analyzer, Gas, Helium, Gaseous-Phase Regulation Number：868.164 Regulation Description：Helium gas analyzer. Life Sustaining：N Implant：N
| Device | Analyzer, Gas, Helium, Gaseous-Phase |
| Regulation Description | Helium gas analyzer. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Product Code | BSE |
| Premarket Review | Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C) |
| Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C) | |
| Submission Type | 510(k) |
| Regulation Number | 868.164 |
| Device Class | 2 |
| Total Product Life Cycle (TPLC) | TPLC Product Code Report |
| GMP Exempt? | No |
| Summary Malfunction | Eligible |
| Reporting | |
| Implanted Device? | No |
| Life-Sustain/Support Device? | No |
| Third Party ReviewEligible for 510(k) Third Party Review Program | |
| Accredited Persons | |
| Beanstock ConsultingGlobal Quality And Regulatory ServicesRegulatory Technology Services, LlcThird Party Review Group, Llc | |
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