510(k) K990039
K990039 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "GAMBRO DQM 200". The FDA issued a decision of Substantially Equivalent on January 27, 2000. The device falls under product code LFP (Conductivity Rate, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Gambro Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2000
- Date Received
- January 6, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conductivity Rate, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type