510(k) clearance
RP Check (RP01)
- 510(k) number
- K260671
- Applicant
- MD Diagnostics, Ltd.
- Decision date
- Oct 26, 2026
- Date received
- Mar 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- CAP
- Device type
- Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- Device class
- Class II
- Regulation
- 21 CFR 868.2600
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Chatham, GB