DormoTech NLab— 510(k) K242290
Substantially EquivalentDormotech Medical, Ltd.
FDA 510(k) clearance K242290 for DormoTech NLab, Substantially Equivalent on 2025-01-08. Applicant: Dormotech Medical, Ltd.. Device class: 2.
Clearance details
- Applicant
- Dormotech Medical, Ltd.
- Product code
- 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
- Afula, IL
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