510(k) K083892
K083892 is an FDA 510(k) premarket notification submitted by Cas Medical Systems, Inc. for the device "FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)". The FDA issued a decision of Substantially Equivalent on March 19, 2009. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Cas Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2009
- Date Received
- December 29, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type