Luma Wrap— 510(k) K142416
Substantially EquivalentSalter Labs
FDA 510(k) clearance K142416 for Luma Wrap, Substantially Equivalent on 2015-06-12. Applicant: Salter Labs. Device class: 2.
Clearance details
- Applicant
- Salter Labs
- Product code
- Code PDH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5700
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code PDH
view allMore clearances from Salter Labs
view all- K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
- K161719 — Salter Labs Bubble Humidifier
- K151874 — BiNAPS Nasal Airflow and Snore Transducer +1 more
- K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
Data sourced from openFDA. This site is unofficial and independent of the FDA.