510(k) clearance
Disposable Belts for Polysomnography (CNSAC)
- 510(k) number
- K260949
- Applicant
- CNSAC Medshop GmbH
- Decision date
- Sep 24, 2026
- Date received
- Mar 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MNR
- Device type
- Ventilatory Effort Recorder
- Device class
- Class II
- Regulation
- 21 CFR 868.2375
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Theilheim, DE