510(k) K860854
K860854 is an FDA 510(k) premarket notification submitted by Cygnus of South Florida, Inc. for the device "CRITICALC". The FDA issued a decision of Substantially Equivalent on December 8, 1986. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Cygnus of South Florida, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1986
- Date Received
- March 7, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type