Algesimeter, Manual
The Algesimeter, Manual is a manually operated device used to measure a patient's pain threshold or sensitivity by applying a controlled mechanical stimulus, such as pressure, assisting in clinical pain assessment and anesthetic evaluation. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is BXL, regulated under 21 CFR 868.1030 in the Anesthesiology specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- BXL
- Device Class
- FDA class 1
- Regulation Number
- 868.1030
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K833326 | MINI OX III OXYGEN MONITOR | Nov 03, 1983 | Substantially Equivalent | Catalyst Research Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.