RED DOT 2269 INFANT MONITORING ELECTRODE— 510(k) K902080
Substantially Equivalent3M Company
FDA 510(k) clearance K902080 for RED DOT 2269 INFANT MONITORING ELECTRODE, Substantially Equivalent on 1990-07-18. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- Product code
- Code DRX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cottae Grove, MN, US
Recent devices under product code DRX
view allMore clearances from 3M Company
view all- K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE +3 more
- K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493 +4 more
- K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more
- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Adverse events under product code DRX
product code DRX- Death
- 6
- Injury
- 476
- Other
- 2
- Total
- 484
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.