BREATH-EASY, MODIFICATION— 510(k) K914416
Substantially EquivalentIcor AB
FDA 510(k) clearance K914416 for BREATH-EASY, MODIFICATION, Substantially Equivalent on 1992-06-23. Applicant: Icor AB. Device class: 1.
Clearance details
- Applicant
- Icor AB
- Product code
- Code HME
- Device class
- Class 1
- Regulation
- 21 CFR 886.1140
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bromma, SE
Recent devices under product code HME
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- K952823 — FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
- K941987 — HEAT AND MOISTURE EXCHANGERS AND FILTERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.