DRAEGER JAUNDICE METER JM-105— 510(k) K133175
Substantially EquivalentDraeger Medical Systems, Inc.
FDA 510(k) clearance K133175 for DRAEGER JAUNDICE METER JM-105, Substantially Equivalent on 2014-11-13. Applicant: Draeger Medical Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Draeger Medical Systems, Inc.
- Product code
- Code MQM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1113
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
Recent devices under product code MQM
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view allRecalls naming K133175
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 K133175.
Data sourced from openFDA. This site is unofficial and independent of the FDA.