AVIATOR TRANSPORT INCUBATOR— 510(k) K081399
Substantially EquivalentInternational Biomedical, Ltd.
FDA 510(k) clearance K081399 for AVIATOR TRANSPORT INCUBATOR, Substantially Equivalent on 2008-06-06. Applicant: International Biomedical, Ltd.. Device class: 2.
Clearance details
- Applicant
- International Biomedical, Ltd.
- Product code
- Code FPL
- Device class
- Class 2
- Regulation
- 21 CFR 880.5410
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Recent devices under product code FPL
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- K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K093260 — AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.