Analyzer, Gas, Helium, Gaseous-Phase
The Analyzer, Gas, Helium, Gaseous-Phase is an instrument used to measure the concentration or partial pressure of helium in respiratory gas mixtures, primarily in anesthesiology and pulmonary function testing contexts. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed device. The product code is BSE, regulated under 21 CFR 868.1640 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- BSE
- Device Class
- FDA class 2
- Regulation Number
- 868.1640
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K903939 | PANDA HELIUM GAS ANALYZER | Jan 03, 1991 | Substantially Equivalent | Medical Associated Services, Inc. |
| K843843 | HE TEST | Dec 04, 1984 | Substantially Equivalent | Erich Jaeger, Inc. |
| K841858 | SPIROLOOP | Jul 11, 1984 | Substantially Equivalent | Datamed, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.