510(k) K863471
K863471 is an FDA 510(k) premarket notification submitted by Colorado Medical, Inc. for the device "COLORADO MEDICAL MODEL PTC 1000". The FDA issued a decision of Substantially Equivalent on October 2, 1986. The device falls under product code KXM (System Accessories, Extracorporeal), a Class II device regulated under 21 CFR 876.5820. Colorado Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1986
- Date Received
- September 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System Accessories, Extracorporeal
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type