← FDA Medical Device Classifications
Devices, Breath Trapping, Alcohol
DJZ · Class I — Low Risk (general controls) · Clinical Toxicology · 21 CFR 862.3050
Classification
- FDA Product Code
DJZ
- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 862.3050
- Review panel
- TX
- Medical specialty
- Clinical Toxicology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 28
- Registered establishments
- 41
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown