INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor— 510(k) K182868
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K182868 for INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor, Substantially Equivalent on 2019-01-08. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Code MUD
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Recent devices under product code MUD
view allMore clearances from Covidien, LLC
view all- K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT) +1 more
- K253984 — Instrument Exit Point on Touch Surgery Aide
- K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN)
- K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula +4 more
Adverse events under product code MUD
product code MUD- Malfunction
- 467
- Total
- 467
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 K182868
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 K182868.
Data sourced from openFDA. This site is unofficial and independent of the FDA.