← FDA Medical Device Classifications
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
NHP · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1500
Classification
- FDA Product Code
NHP- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 868.1500
- Review panel
- AN
- Medical specialty
- Anesthesiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 49
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown