IN-VISION IMAGING SYSTEM— 510(k) K031148
Substantially EquivalentJomed, Inc.
FDA 510(k) clearance K031148 for IN-VISION IMAGING SYSTEM, Substantially Equivalent on 2003-05-28. Applicant: Jomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Jomed, Inc.
- Product code
- Code DXK
- Device class
- Class 2
- Regulation
- 21 CFR 870.2330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rancho Cordova,, CA, US
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More clearances from Jomed, Inc.
view all- K031346 — JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
- K031277 — JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
- K022762 — JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
- K021219 — SMARTWIRE/SMARTMAP PRESSURE SYSTEM
- K003938 — TRAK BACK II
Data sourced from openFDA. This site is unofficial and independent of the FDA.