510(k) K902716
K902716 is an FDA 510(k) premarket notification submitted by Prucka Engineering, Inc. for the device "PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)". The FDA issued a decision of Substantially Equivalent on September 4, 1990. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Prucka Engineering, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1990
- Date Received
- June 20, 1990
- 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