510(k) K133175
K133175 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "DRAEGER JAUNDICE METER JM-105". The FDA issued a decision of Substantially Equivalent on November 13, 2014. The device falls under product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System), a Class I device regulated under 21 CFR 862.1113. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2014
- Date Received
- October 17, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bilirubin (Total And Unbound) In The Neonate Test System
- Device Class
- Class I
- Regulation Number
- 862.1113
- Review Panel
- CH
- Submission Type