← FDA Medical Device Classifications
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EPE · Class I — Low Risk (general controls) · Anesthesiology · 21 CFR 868.5795
Classification
- FDA Product Code
EPE- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 868.5795
- Review panel
- AN
- Medical specialty
- Anesthesiology
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 66
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown