INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003— 510(k) K061901
Substantially EquivalentIno Therapeutics
FDA 510(k) clearance K061901 for INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003, Substantially Equivalent on 2006-12-14. Applicant: Ino Therapeutics. Device class: 2.
Clearance details
- Applicant
- Ino Therapeutics
- Product code
- Code MRN
- Device class
- Class 2
- Regulation
- 21 CFR 868.5165
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middleton, WI, US
Recent devices under product code MRN
view allMore clearances from Ino Therapeutics
view allAdverse events under product code MRN
product code MRN- Death
- 9
- Malfunction
- 910
- Total
- 919
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K061901
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061901.
Data sourced from openFDA. This site is unofficial and independent of the FDA.