NVV · Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
Clinical Chemistry · 21 CFR 862.2100 · Class 1
Overview
| Product Code | NVV |
|---|---|
| Device Name | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System |
| Regulation | 21 CFR 862.2100 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.
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 § 862.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
