Cirona 6400— 510(k) K161209
Substantially EquivalentDevon Medical Products
FDA 510(k) clearance K161209 for Cirona 6400, Substantially Equivalent on 2016-05-31. Applicant: Devon Medical Products. Device class: 2.
Clearance details
- Applicant
- Devon Medical Products
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- King Of Prussia, PA, US
Recent devices under product code JOW
view allMore clearances from Devon Medical Products
view all- K151189 — Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
- K151240 — extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
- K143362 — extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
Data sourced from openFDA. This site is unofficial and independent of the FDA.