BXL · Algesimeter, Manual
Anesthesiology · 21 CFR 868.1030 · Class 1
Overview
| Product Code | BXL |
|---|---|
| Device Name | Algesimeter, Manual |
| Regulation | 21 CFR 868.1030 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
| GMP Exempt | Yes |
Identification
A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833326 | MINI OX III OXYGEN MONITOR | Catalyst Research Corp. | Nov 3, 1983 | SESE |
Top Applicants
- Catalyst Research Corp. — 1 clearance
