Disposable Belts for Polysomnography (CNSAC)— 510(k) K260949
Substantially EquivalentCNSAC Medshop GmbH
FDA 510(k) clearance K260949 for Disposable Belts for Polysomnography (CNSAC), Substantially Equivalent on 2026-09-24. Applicant: CNSAC Medshop GmbH. Device class: 2.
Summary
These are disposable belts for polysomnography (sleep studies), filed under MNR, ventilatory effort recorders. The record doesn't describe the belts or say which recording systems they connect to.
Class II, 21 CFR 868.2375. The Anesthesiology panel reviewed it as a Traditional 510(k).
CNSAC Medshop GmbH filed from Theilheim, Germany. Review took 185 days (March 23 to September 24, 2026).
Clearance details
- Applicant
- CNSAC Medshop GmbH
- Product code
- Product code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Theilheim, DE
Recent devices under product code MNR
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